Quantitative and Qualitative Analysis of Different Generic

Paracetamol 500mg Tablet

Mary Cristine Grace Panuelos (a), Ruth Ann Belison (b), Beryl Mira Yu(c), Marie Esthel Familar(d), Marie
Kathleene Sahagun(e), Jeena Sandra Manrique(f)
Pacific Surgical Inc.,-Makati City (a) , The Medical City- Pasig City (b) , Centro Escolar University, Graduate SchoolManila City(c) De La Salle Health Science Institute- Damarinas City(d), Interphil Laboratory-Laguna(e) , Centro Escolar
University, Graduate School- Manila (f)
Email:cristine_panuelos@yahoo.com

ABSTRACT
Paracetamol is classified as an analgesic and antipyretic medicine that is available to the public over the
counter without a prescription. The researchers aim to determine the amount of Paracetamol content and to establish
the pharmaceutical equivalence of the different generic Paracetamol 500 mg tablets available in various pharmacy
stores in Metro Manila. The quality control parameters which were studied are weight uniformity, tablet hardness,
friability, disintegration and dissolution test specified United States Pharmacopeia (USP). Weight variation, friability
test and hardness value requirement was complied by all generic Paracetamol 500mg tablets. Disintegration time for
all test samples were less than fifteen (15) minutes, also complied the USP limit. All generic Paracetamol 500mg
tablet showed more than 80% drug release within forty (45) minutes. The Paracetamol content of all test samples
contains not less than 90%. In this study the results obtained from the different tests shows that all test samples are
within the acceptable range according to the official United States Pharmacopeia (USP) limit.
Keywords: Paracetamol, Analgesic, Antipyretic United States Pharmacopeia (USP), UV-Vis Spectrophotometer

INTRODUCTION
Acetaminophen or Paracetamol is a pharmaceutical
product classified as an analgesic, which relieves pain
and an antipyretic which reduces fever. It is also
sometimes classified as a non-steroidal antiinflammatory drug (NSAID). (Lippincott,2015)
The drug, which comes in both Generic and Branded
medicines available in the market, were manufactured
by different companies from different countries. Like
any other medicines, it is available in different drug
dosage forms such as syrup, tablet, caplet, parenteral
and suppository. (Mahato et al, 2016).
Panadol, is the most widely available brand, sold in
over 80 countries. In 1984 the pharmaceutical field for
generic drugs altered substantially. This was the year
when the bill, now known as the Hatch-Waxman Act,
proposed by Senators Orrin Hatch and Henry A.
Waxman was approved, making it easier for generic
drugs to enter the market. This Generic drug must be
of the same pharmaceutical activity, dosage form and

route of administration as the reference drug.

Differences should only limit to shape, color, size,
packaging and inactive ingredient. (WebMD,
LLC,2015-2016)
The Researchers aims to determine if the amount of
different generic Paracetamol 500mg tablets sold
from various pharmacies in Manila are within the
official United States Pharmacopeia (USP) limit.
MATERIALS AND METHODS
Different generic Paracetamol 500mg tablet was
purchased from various pharmacy stores in Metro
Manila. Two (2) Paracetamol tablet were locally
manufactured by local manufacturers in the
Philippines while the other two (2) Paracetamol tablet
was manufactured from India and China.
Uniformity in Weight. A total of ten (10) tablets were
weighed individually using a digital balance with a
precision of 0.05mg and readability of 0.1mg. The
mean and average weight were calculated to

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determine to determine the uniformity of each

samples.
Hardness test. Ten (10) tablets will be tested using
the Monsanto tablet hardness tester. The average of
the force used to break the tablet will be noted.
Friability Test. The friability of ten (10) tablets was
determined using the Tablet Friabilator Tester CS-4.
Preweighed sample of tablets was placed in the
friabilator revolving at 25rpm and were subjected to
100 revolutions. Tablets were dusted using a soft
muslin cloth and reweighed.
Disintegration Test. The apparatus to be used is
Basket-rack Assembly.
One (1) sample tablet will be placed inside each of
the six chambers of the apparatus. A disk will be
placed inside the chamber. A temperature of 372C
is maintained. Observe if the samples disintegrate
completely and time will be noted.
If some tablets fail to disintegrate then the test will be
repeated using 12 more tablets. The requirement of
disintegration test is acceptable if not less than 16 of
the tablets used disintegrate.
Dissolution test: Drug release from different generic
Paracetamol tablets was performed using USP XXII,
type II apparatus (paddle). Dissolution of tablets was
carried out in 900ml phosphate buffer pH5.8 as
dissolution medium; paddle was rotated at 50rpm with
bath temperature of 37 1C. At every 15 minutes
time interval 5ml of sample was withdrawn from the
dissolution medium to maintain the volume constant.
After filtration and appropriate dilution, the sample
solutions were analyzed at 244nm using Genesys
10S UV-VIS Spectrophotometer. The amount of drug
present in the samples was calculated.
RESULTS
The physicochemical analyses of four
Paracetamol tablets were shown in Table 1.

The disintegration time was tested and results obtained

shows Sample 3 and 4 have the same disintegration
time while Sample 1 and 2 did not cross the time of
15mins duration.
Dissolution test shows that all test samples were
dissolved in not less than 80% in 45mins.
Drug content in test sample
The percentage amount of acetaminophen obtained
in the test samples was determined by the use of UV
VIS Spectrophotometer. The test samples rendered
an amount of Paracetamol ranging from 103.79% 109.17%. The absorbances obtained during the
experimental study were shown in Table 2.
Table 1: Qualitative Analysis of Paracetamol tablets

Parameters
tested

S1

S2

0.61

0.57

0.63

0.58

Hardness Test
(kg/cm2)

11.18

10.68

10.75

10.15

Friability Test (%)

0.19

0.29

0.02

0.41

Disintegration
time
(mins)

Dissolution
time (%)
(after 30mins)

70

85

85

80

Dissolution time
(%)
(after 45mins)

80

98

98

85

Average Weight
(g)

S3

S4

Table 2: 244 nm Absorbance & Assay of Paracetamol tablets

generic

Then average weight of each tablet ranges from 0.57g

0.63g.
The results obtained for tablet hardness ranges from
10.15kg/cm2 - 11.18kg/cm2

Parameters

S1

S2

S3

S4

Absorbance

0.0485

0.0512

0.0490

0.0488

% Labeled
claim

109.17

104.43

107.54

103.79

In the friability test, all brands showed values within the

acceptable limit. The friability values for the different
Paracetamol tablet brands ranges from 0.02 to 0.41%.

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DISCUSSION
The purpose of this study was to compare and
evaluate the quality standards of commercially
available generic Paracetamol 500mg tablets. They
were evaluated for the physical and chemical
parameters. Qualitative test was performed such as
weight uniformity, tablet hardness, friability test,
disintegration and dissolution test. Quantitative
analysis
was
performed
using
Uv-Vis
Spectrophotometer to determine the amount of
acetaminophen.
According to the United State of Pharmacopoeia
(U.S.P), the tablets active ingredient which is
Paracetamol, should contain not less than 90%
(450mg) and not more than 110% (550mg).
The USP states that not less than 80% of
Acetaminophen tablet must be dissolved in 45mins
dissolution time. Table 1 show that all samples are
within the acceptance criteria.
The results obtained from the analyzed samples
rendered a percentage ranges from 103.79% 109.17% using Uv-Vis Spectrophotometer indicating
none of the samples contains less than 90% of
Paracetamol content.
The results of disintegration time in Table 1 shows
that all test samples are within the acceptance criteria
of United States Pharmacopoeia that all core tablets
should not cross 15mins duration during disintegration
process. Sample 3 and 4 were easily disintegrated in
2minutes.
According to BP/USP friability should not be more
than 1%, Sample 2 has greater friability than the three
(3) samples.
There is no official limit for hardness of tablet. Test
samples obtained a range from 10.15 kg/cm2
11.18kg/cm2.
CONCLUSION
Results obtained from qualitative and quantitative
tests performed on different generic Paracetamol 500
mg tablet shows that all test samples are within the
acceptance criteria of United States Pharmacopoeia.

of administration. To further validate the results of the

study, a batch to batch testing and increasing the
number of trials can be conducted.
ACKNOWLEDGEMENTS
The Researchers would like to extend their sincerest
gratitude to the following people who supported this
research study
Faculty and Staff of the Industrial Pharmacy
Department, University of the Philippines Manila.
Pharmacy Laboratory, Centro Escolar UniversityMakati.
College of Pharmacy, De La Salle Health InstituteDasmarinas Cavite.
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RECOMMENDATION
The Researchers recommend to tests other plain
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