International Journal of Pharma and Bio Sciences V1(1)2010

Photostability Studies And Development Of Fast Release Nifedipine Tablets

M.A. SHENDE*1 and T. MARKANDEEYWAR2

1
B.K. College of pharmacy, Nagzira Road, Sakoli, Dist- Bhandara (M.S) India;
2
I.S.F. College of pharmacy, G.T. road moga, Ghal kalan, Punjab, India;

*Corresponding author mulchandshende@yahoo.com

ABSTRACT

In the present study, an attempt has been made to improve the physiochemical stability of
nifedipine by complexation using weak cation-exchange resins, indion 204 and indion 264 to eliminate
light decomposition tendency of drug. Tablets were prepared by Indion 204: drug complex using
optimized ratio with different diluents. Irradiation test for drug degradation was carried out by
comparing pure nifedipine drug, methanolic drug solution, resinates and prepared tablets formulation to
determine differences in the effectiveness of artificial light and natural indirect sunlight sources. The
tested resinate of nifedipine and optimized formulation was likely to be photostable up to at least 10
weeks of continuous artificial and natural day light exposure. In-vitro drug release studies showed more
than 90% drug release within 30 min and exhibited similar dissolution profile with commercial tablets.
Indion 204 was found to be better complexing agent for reducing the photosensitivity and to design
stable nifedipine tablets.

KEYWORDS
Nifedipine, Photostability, Indion 204, Indion 264 and Ion-exchange resin

INTRODUCTION hypertension, angina pectoris, and other

Nifedipine, 1, 4-dihydro-2, 6-dimethyl-4-
(2-nitrophenyl)-3, 5-pyridine dicarboxylic acid
dimethyl ester is the prototype compound of the
dihydropyridine class of calcium channel
antagonists. Nifedipine is a selective arterial
dilator, and is used for the treatment of
cardiovascular disorders1-4. Nifedipine can
undergo photodegradation accompanied by loss
of pharmacological activity and even toxic
products when they are irradiated by ultra-violet/
visible lights. This process involves the reduction
of the aromatic nitro group to nitroso group or the

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 International Journal of Pharma and Bio Sciences
Photostability Studies And Development Of Fast Release Nifedipine Tablets
oxidation of the dihydropyridine ring to a
pyridine ring5. For the safety of patient, it is
important to note that the patient must have to
receive a uniform dose of drug throughout the
whole of the shelf life of product. Instability of a
drug product may lead to decrease in
bioavailability. Several studies related to its
photodecomposition have been reported6-9.
Manufacturers of nifedipine products use
light resistant coating or packing to minimize
their photodegradation. Long term exposure to
sunlight or artificial light may also occur if
nifedipine formulations are improperly stored by
patients. Poor storage conditions may potentially
decrease clinical efficacy of nifedipine
products10. The selection of ingredients within the
dosage form can be optimized in order to reduce
photosensitivity. Ion-exchange resins are solid
and suitably high molecular weight
polyelectrolytes that can exchange their mobile
ions of equal charge with surrounding medium
reversibly and stoichiometrically. Ion-exchange
resins have versatile properties as drug delivery
vehicles and have been extensively studied in the
development of novel drug delivery systems11.
Ion-exchange resin can form complex with
nifedipine and its utility used to withstand drug in
light environment. Ion-exchange resins i.e. indion
204 and indion 264 were chosen as a carrier to
provide stability to the drug product. Manek and
Kamat evaluated Indion CRP-244 and CRP-254
resins as sustained release and taste masking
agents12. This research is the one to report
photostability of nifedipine and focus on one of
the important application of ion-exchange resins
by formation of drug-resin complex to develop
stable nifedipine tablet. The present study also
compares photodegradation of authentic
nifedipine powder, resinate of nifedipine and
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V1(1)2010
methanolic nifedipine solution. The literature
survey revealed that no work has been reported
for stability using these ion-exchange resins.
MATERIALS AND METHODS
Nifedipine was provided as a gift sample
by J. B. Chemicals and Pharmaceuticals ltd.
Mumbai, India. Indion 204 and indion 264 were
gifted by Ion Exchange (India) Ltd., Mumbai,
India. Other chemicals used were of AR grade.
(i) Preparation of drug-resin complexes
(Resinates):
Resinates were prepared by the batch
process. An accurately weighed amount of a
nifedipine (100mg in all instances) was taken in
100 ml of methanol: water (60:40). Then a known
weight of ion exchange resin was added in ratio
of drug-resin, 1:1, 1:2 and 1:4 to the solution and
stirred on a magnetic stirrer until equilibrium was
achieved. Time to reach equilibrium was
determined by periodically measuring
concentration of the drug in solution
spectrophotometrically. Resinates obtained were
separated by filtration, washed with copious
quantity of methanol to remove uncomplexed
drug. The complexes were dried overnight in a
hot air oven at 40C and then stored in tightly
closed dessicator. The amount of drug loading
was determined by finding the difference between
the amount of drug present in the stock solution
and the amount remaining in filtrate at the end of
equilibrium using N. Rahman et al.
spectrophotometric method at 430.0 nm.
(ii) Determination of drug content in the
complexes13:
About 60 mg complex (equivalent to 20
mg of nifedipine) was weighed accurately and
extracted into 50 ml chloroform with shaking and
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 International Journal of Pharma and Bio Sciences
Photostability Studies And Development Of Fast Release Nifedipine Tablets
stirred further for 2 hrs on magnetic stirrer and
then filtered using 0.2 membrane filter. The
filtrate was evaporated to dryness under vaccum
and residue was dissolved in methanol. Aliquots
of 0.05- 0.5 ml of solution of nifedipine was
pipetted into a series of 10.0 ml standard
volumetric flaks. Then 0.6 ml of 0.05M KOH
solution was added into each flask and diluted to
10.0 ml with dimethyl sulfoxide. The contents of
each flask was mixed well at room temperature
(25 10C) and absorption was measured at 430.0
nm against the reagent blank prepared similarly
within stability time period of 2 hours. The
concentration of nifedipine was calculated either
forms a calibration curve or regression equation.
(iii) Drug loading and properties of complex:
Indion 204 and indion 264 were subjected
to different pH condition to find the optimum pH
condition for loading of drug. The ratios of drug
and resin complexes were1:1, 1:2 and 1:4 with
indion 204 and indion 264. The solutions were
stirred for 2 hour. Resinate obtained was
separated by filtration, washed with copious
quantity of methanol and drug content was
determined. Prepared complexes were evaluated
for shape, angle of repose, bulk density, tapped
density, Carrs index, and hausner's ratio14.
(iv) X-ray diffraction Spectroscopy (XRD):
X-ray diffraction spectrum of the pure drug,
indion 204, physical mixture and resinates were
recorded using a Philips PW 1729 x-ray
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V1(1)2010
diffractometer (PW 1729, Philips, Netherland).
The XRD was performed at the diffraction angle
between 5-600 2Q ranges.
(v) In-vitro release of nifedipine from
resinates:
Complexes of nifedipine with indion 204 and
indion 264 were subjected to in-vitro dissolution
studies using USP 24 method. Weighed quantity
of complexes equivalent to normal dose was
suspended in 0.1 N HCl using USP dissolution
apparatus type II. After 5 min interval 5ml of
dissolution medium was withdrawn by pipette for
analysis. Then samples were withdrawn at 15 min
interval. The volume withdrawn was replaced
with fresh quantities of dissolution fluid. The
withdrawn samples were filtered and the quantity
of drug released was determined.
(vi) Formulation of fast release nifedipine
tablets:
The tablets of nifedipine were prepared by
conventional direct compression technique using
various diluents like spray-dried lactose,
microcrystalline cellulose and Maize starch. All
ingredients were passed through the sieve no # 80
to produce uniform powder. Required quantity of
each was taken for particular formulation and the
blend was mixed by tumbling in polythene bag.
The composition of each formulation is given in
Table 1. The hardness of tablet of each batch kept
constant (3-4 kg/cm 2). The weight of tablet of
each batch was adjusted to 240 mg.
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 International Journal of Pharma and Bio Sciences V1(1)2010

Photostability Studies And Development Of Fast Release Nifedipine Tablets

Table 1
Composition of nifedipine tablets.

Ingredient Formulation code

(mg/ tablet) F1 F2 F3
Resinate (drug: resin) 60 60 60
Microcrystalline cellulose 140 - -
Lactose - 140 -
Maize starch - - 140
Polyvinylpyrrolidone
20 20 20
( PVP K-30)
Sodium lauryl sulfate 10 10 10
Talc 6 6 6
Magnesium stearate 4 4 4
(vii) Irradiation test for stability under The FT-IR spectra for pure drug, indion 264,
influence of light: indion 204, physical mixture of drug-resin and
For artificial light irradiation, a 40 W resinates after subjecting to unexposed and
tungsten lamp was used. Nifedipine samples were exposed light were obtained using KBr disk
placed 50 cm from the lamp in a cabinet (1 m 1 method. Spectral measurements were obtained by
m 0.75 m). Nifedipine powder samples (10 mg) powder diffuse reflectance on FT-IR
were placed in 10 ml clean glass vials, irradiated spectrophotometer (Shimadzu, 8033) in the wave
from 0-12 days and samples were collected at 0, 1, number region 400-4000 cm-1 to find out
7, 10 and 12 days. Also a total of 11 1 ml compatibility and stability of drug15.
methanolic nifedipine solution samples (10 g/ml) (ix) Post compression parameters:
were placed in 5 ml clear glass vials and irradiated After tablets compression, weight variation,
for a period of 0-240 min. Samples were taken at 0, friability, content uniformity and disintegration
15, 30, 45, 60, 120, 240 mins. The experiments time was determined. In-vitro dissolution studies
were conducted at ambient temperature. Exposure were carried out in USP dissolution test apparatus
to indirect sunlight was also used during the spring type II, using pH 1.2 dissolution fluids at 100
months to compare the efficacy of artificial light rpm16, 17.
and natural room daylight in photodecomposition
of nifedipine. Resinates, prepared and marketed RESULTS AND DISCUSSION:
DISCUSSION
tablet samples were irradiated from 0-10 weeks in The most obvious result of drug
artificial light and indirect sunlight. Samples were photodecomposition is loss of potency of the
collected at 0, 1, 2, 4, 8 and 10 weeks intervals10. product; therapeutically inactive a more
pronounced is the degraded product is toxic.
(viii) Fourier Transformed Infrared Stability testing is therefore an essential part of
Spectroscopy (FT-IR): product development and there is need to ensure
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 International Journal of Pharma and Bio Sciences
Photostability Studies And Development Of Fast Release Nifedipine Tablets
that satisfactory product quality is maintained
during practical usage.
Complexation between the drug and resin is
essentially a process of diffusion of ions between
the resin and surrounding drug solution. The step-
by-step studies were carried out to ion-exchange
resin to provide stability to the drug. For
preparation of resinates, batch method was
preferred because of its convenience. As the
reaction is an equilibrium phenomenon, maximum
efficiency in shorter time is best achieved in batch
process. Also, higher swelling efficiency in batch
process results in more surface area for ion-
exchanged. Hence the batch process is suitable for
smaller particles18. Various experimental
conditions were optimized to get optimum drug
loading. Time to reach equilibrium for drug
loading was found to be 6 hrs. To investigate effect
of pH on drug loading, the varying pH of drug-
resin solution was kept the drug: resin in the ratio
1:2, and results are recorded in Table 2.
Table 2
Effect of pH on Drug Loading.
% Drug content per gram of resinate
pH Ratio (mean S.D., n=3)
Indion 204 Indion 264
1 37.25 0.28 34.45 0.48
2 40.2 0.61 37.5 0.25
4 1:2 44.10 0.49 40.10 0.60
6 48.12 0.15 46.50 0.65
8 42.06 1.42 41.06 0.12
The loading of nifedipine on cation-
exchange resin is an equilibrium process, which
depends upon the presence of the cations in the
solution. This is dictated by the pH of solution,
which may affect the amount of ionized drug
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species present in the solution thereby affecting
loading efficiency. The results showed that lower
loading of nifedipine was observed at low pH,
which might be due to the higher concentration of
competing ions which may inhibit the interaction
of resins. At pH 6, maximum loading of nifedipine
was obtained. Hence, pH 6 was selected for
complexation of nifedipine with indion 204 and
indion 264. Effect of drug: resin ratio on loading is
shown in Figure 1. It shows that 1:2 drug: resin
ratio shows maximum drug loading.
% Drug per gram resinate
50
40
30
20
10
0
1;1 1;2 1;4
Drug:resin ratio
Indion 204 Indion 264
Figure 1
Percent of nifedipine loaded on resinate ratio
(MeanSD, n=3)
Increase in the amount of complexing agent
increases the amount of drug adsorbed as number
of sites increases, but the drug content per gram of
the complex decreases. Thus resinate prepared by
batch method using indion in drug: resin ratio of
1:2 at pH 6 gave optimum drug loading. In-vitro
release profile of complex is shown in Figure 2.
Studies showed that drug-Indion 204 complexes
better release than drug- indion 264 complexes.
While more than 90% of drug release from indion
204 and indion 264 in just 30 min and 40 min
respectively. Reichenberg (1953) in his study
discussed release of drug from ion-exchange
resins. He described release of two types (1) Film
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Photostability Studies And Development Of Fast Release Nifedipine Tablets

Figure 2
In-vitro drug release profile from resinates
(MeanSD, n=3)

120
diffusion, which is dependent on ingoing ion
100
concentration, and (2) particle diffusion which is

Cumulative % drug release

80
independent of concentration of ingoing ions19.
60
40
The complexation was confirmed by carrying out 20
x-ray diffraction studies on indion 204 and indion 0
264 resins, drug, drug complex, and physical 0 20 40 60 80
mixture of two. Time (Minute)
Indion 204 resinate Indion 264 resinate

Figure-3
X-ray powder diffraction pattern of a) pure nifedipine b) indion 204 resin c) physical
mixture of drug-resin d) drug-resin complex (resinate)

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Photostability Studies And Development Of Fast Release Nifedipine Tablets

The x-ray powder diffraction showed crystalline peak characteristics of drug were masked and
characteristic amorphous characteristics of the complex were prevalent confirming the complexation
(fig.3). The characteristics hump shown by a typically amorphous structure of resin was also not seen in
drug resinates and the physical mixture of two (drug and resin) showed mixed pattern. Studies have
shown that the molecules of entrapped drug changes from the crystalline to amorphous state.
Photostability of nifedipine was determined after exposure to indirect natural light and continuous
artificial light. Studies has shown that natural and 20 W tungsten artificial light have similar effects in
the photodecomposition.
Table 2

Results of photodegradation obtained by exposure to artificial and natural light (n=3).

Percentage nifedipine (w/w initial nifedipine content)

Time methanolic
Nifedipine Formulated Protected
solution of Resinate 204 Resinate 264
drug tablet marketed tablet
nifedipine
Artif Natu Artifi Natur Artifi Natu Artifi Natu Artifi Natu Artific
Natural
icial ral cial al cial ral cial ral cial ral ial
light
light light light light light light light light light light light

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Photostability Studies And Development Of Fast Release Nifedipine Tablets

0 100 100 100 100 100 99 99

90 82.5 - - - - - - - - - -
15
2 1
88.4 80.5 - - - - - - - - - -
30
3 1
86.4 80 - - - - - - - - - -
Min. 45
1 2
83.6 76.5 - - - - - - - - - -
60
0.8 1
72.8 60.3
120 - - - - - - - - - -
3 1
54.2 40
240 - - - - - - - - - -
1 3
- - 92 83 - - - - - - - -
1
2 3
- - 81.2 68
3 - - - - - - - -
1 2
- - 80.5
Day 7 621 - - - - - - - -
1
- - 76.3 56.5 - - - - - - - -
10
0.8 0.9
- - 69.6 52.8 - - - - - - - -
12
1 3
- - - - 99.5 99.8 99.6 99.9 98.5 101 98.9 99.7
1
1 2 0.9 2 1 0.9 1 0.9
- - - - 98.7 99.6 98.5 99.8 98.6 99.8 98
2 98.9
1 2 3 2 3 1 1
- - - - 98.7 99 98.3 99 98.6 98.4 98.8 98
Weak 4
1 2 2 1 1 1 2 2
- - - - 98.4 98.4 98.1 97.4 98.3 97.5 98.4 96.8
8
0.8 0.9 1 2 1 0.6 2 2
- - - - 97.8 97 96.8 98.1 96.7 98.5 95.6
10 982
2 0.9 2 2 0.9 2 0.9

Nifedipine methanolic solution exposed to
natural indirect sunlight was completely
photodecomposed in 15 min. The result shows that
the efficacy of natural indirect sunlight in
photodecomposition of nifedipine is more than
artificial light due to the fact that the intensity of
natural light. Therefore, these results are evidence
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for that artificial light can not be used alone in
photodecomposition studies. Photodegradaition of
nifedipine methanolic solution and nifedipine
powder after artificial light and natural irradiation
are shown in Table 2. Photodegradation of
nifedipine powder measured as the loss percentage
of nifedipine, exceeded 8.0 % and 17.0%, in
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 International Journal of Pharma and Bio Sciences
Photostability Studies And Development Of Fast Release Nifedipine Tablets
approximately 24 hrs after artificial and natural
indirect light irradiation respectively.
The percentage of nifedipine content was measured
in all resinates and tested formulations irradiated
for up to 10 weeks by artificial and natural light.
Results showed that differences between data
obtained were not significant and none of the
tested nifedipine formulations and resinate
underwent any appreciable decomposition (>
10%), even after 10 weeks irradiation. Pure
nifedipine degrade higher amount than tablet
containing nifedipine. Dosage forms containing
excipients does not affect on method for
determination and decomposition of nifedipine.
For more confirmation IR spectra of unexposed
nifedipine (fig.4) shows the NH stretching, CH
aromatic stretching, CH alkyl stretching, C=O
carbonyl stretching and NO2 stretching bonds
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V1(1)2010
attribute to the identity and purity of drug. The IR
spectra of the unexposed physical mixture of
nifedipine with indion 204 and indion 264 shows
the same absorption bands for NH, CH aromatic
stretching, CH alkyl stretching, C=O carbonyl
stretching and NO2 stretching and similarity in the
finger print region indicated drug is compatible
with both resins. But in case of exposed physical
mixture, the absence of NH stretching and
significant difference in fingerprint region
compared with unexposed physical mixture
showed the degradation of the drug in light. The
similarity in the functional and finger print region
of the IR spectra of unexposed resinate and
exposed resinate of nifedipine, attributed the
stability of the drug in the complex form with both
resins.
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 International Journal of Pharma and Bio Sciences V1(1)2010

Photostability Studies And Development Of Fast Release Nifedipine Tablets

Figure-4
IR spectra of pure nifedipine, physical mixture of resin-drug and resinates of nifedipine after
irradiation and non-irradiation

Results of angle of repose, bulk and tapped density, Carr's index and Hausner's ratio are depicted
in Table 3. The results showed that resinates exhibits good flow and good packing. When the %

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Photostability Studies And Development Of Fast Release Nifedipine Tablets

compressibility ranges from 5 to 16 and Hausner ratio close to 1 the materials have acceptable flow
property and packing ability.
Table 3
Physical Properties of Resins and Resinates (Mean SD, n = 3)

Character Resins Resinates

Indion 204 Indion 264 204 264
Shape Irregular Irregular Irregular Irregular
Angle of repose 20.4 28.66 22.76 28.58
Bulk density 0.688 0.640 0.638 0.641
Tap density 0.776 0.761 0.670 0.681
Carrs index 15.6 16.8 14.13 15.48
Hausner Ratio 1.20 1.26 1.30 1.28

The formulated tablets were evaluated for
disintegration time, weight uniformity, %
friability, and content uniformity as shown in
Table 4. The formulated tablets in all the cases
possessed good mechanical strength with
sufficient hardness. The friability values of all the
formulations were within the limit i. e less than
1.0%. All the tablets from each formulation passes
weight variation test, as the % weight variation
was within the pharmacopoeial limit. In-vitro
disintegration times as per IP were determined for
all formulations. It was found that tablets prepared
with MCC as diluent, disintegrated faster than
lactose and maize starch. This is because the
tablets comprising water-soluble filler tends to
dissolve rather than disintegrate. The dissolution
parameters of formulated and marketed tablets are
summarized in table 4. No variations were
observed in the dissolution characteristics of the
tablets formulated and marketed. All dissolution
parameters indicated rapid and higher dissolution
of nifedipine from formulated tablets than market
tablets. Dissolution efficiency (DE30) values were
calculated as suggested by Khan20.
Dissolution efficiency (DE30) and
disintegration time of formulation F2 and F3 was
found to be poor than F1. Figure 3 shows that
formulated and conventional tablets showed
dissolution and percent cumulative drug release at
the end of 55 minute was 98 %. The formulation
F1of nifedipine with microcrystalline cellulose as
filler was found to be optimum as it shows lowest
disintegration time with desired dissolution rate.
This study indicates that nifedipine tablet prepared
from drug: Indion 204 (1: 2) complex might be
suitable for commercial supply dosage form.

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Photostability Studies And Development Of Fast Release Nifedipine Tablets

Figure 3
In-vitro drug release from nifedipine tablets (Mean SD, n = 3)
cumulative % drug release

150

100

50

0
0 10 20 30 40 50 60 70
Time (Minute)
Folrmulation-F1 Marketed tablet

Table 4

Physical properties and dissolution characteristics of nifedipine tablet formulated and marketed
samples

Weight
Disintegration % Content T50 DE30 K
Formulation Uniformit
time (s) Friability Uniformity (%) (min-1)
y
F1 3121.2 241.22.36 0.68 98.850.73 14.5 40.18 0.02358
Market Sample
(Uncoated 319.20.5 3011.42 0.75 98.71.2 12.5 39.62 0.0230
tablets)

CONCLUSIONS photodecomposition for nifedipine tablet

Different data generated in this experiment processing. The batch process of complexing
indicates that protect for nifedipine degradation. nifedipine with Indion 204 (1:2) produced efficient
Therefore, resinates of nifedipine used to control drug loading. The study also suggests that an ion-

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 International Journal of Pharma and Bio Sciences
Photostability Studies And Development Of Fast Release Nifedipine Tablets
exchange resin system is reducing photosensitivity
of drug which helps to produce stable tablets.
ACKNOWLDGEMENTS
The authors are grateful to M/s J. B.
Chemicals and Pharmaceuticals ltd. Mumbai for
the supply of as a gift sample nifedipine and to the
Management, B.K. College of pharmacy for
providing the necessary facilities to carry out the
research work.
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