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RESEARCH ARTICLE
Maria Ayub et.al / IJIPSR / 3 (10), 2015, 1457-1462
Department of Pharmaceutics
ISSN (online) 2347-2154
International Journal of Innovative
Pharmaceutical Sciences and Research
www.ijipsr.com
QUALITY ANALYSIS OF DIFFERENT BRANDS OF
ACETAMINOPHEN AVAILABLE IN MARKET
1
Asma Eraj, 1Maria Ayub*
Jinnah University for Women,Karachi 74600, Pakistan
Abstract
Acetaminophen has pronounced antipyretic and analgesics activity. Paracetamol is commonly used for
treating certain mild to moderate pain, including that caused by flu, sprains, cold, headaches,
dysmenorrhea, toothaches and minor arthritis pain. The present study was conducted to analyze,
compare and evaluate the quality standards of commercially available brands of Acetaminophen
(paracetamol) tablets include Panadol, Calpol and Febrol availaible in Pakistan as prescribed by B.P. &
U.S.P. The quality control testing is an important factor of GMP (good manufacturing practices).The
formulation of paracetamol is manufactured by different Multinational and national companies by using
different manufacturing process as well as well as exciepients. The three different brands of paracetamol
tablets (500mg) were evaluated comparatively for their physical parameters. The in-vitro test of all three
brands of paracetamol include disintegration, hardness, friability and weight variation were found to be
varying for each tablet, but within the specified limits. . The result was analyze by using spss 19.0 version
applying one way ANOVA shows significant result between all three brand i.e. panadol, calpol and
febrol. Its mean the value of p > 0.05 (C.I. 95 %) . Therefore it can be concluded that all three brand
avilaible in Karachi meet the USP specification in quality control analysis.
Keywords: Paracetamol, weight variation, Disintegration, Hardness, Friability.
Corresponding Author:
Maria Ayub
Lecturer, Faculty of Pharmacy,
Jinnah University for Women,
Karachi 74600, PAKISTAN
E-mail: [email protected].
Mobile: +92331-3119160
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October Issue
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RESEARCH ARTICLE
Maria Ayub et.al / IJIPSR / 3 (10), 2015, 1457-1462
Department of Pharmaceutics
ISSN (online) 2347-2154
INTRODUCTION
Acetaminophen commonly known as paracetamol, belonging to non-steroidal anti-inflammatory
drugs (NSAIDs), widely used over the counter medicine [3].Chemically, it is 4-hydroxy
acetanilide, its structure shown in Figure 1. [1] .Paracetamol is approved for reducing fever in
people of all ages [2]. It is commonly prescribe for the anti-pyretic agent, analgesics, headaches,
other minor aches and pains, and is a major ingredient in numerous cold and flu remedies [2]. It is
effective and safe for human consumption at the recommended doses [5]. The main objective of
an oral tablet is to deliver the drug to the human body at certain and defined amount through the
gastro-intestinal system for producing therapeutic effect [6]. The drug product formulation can
have a significant effect on the quality control parameters such as weight variation, hardness,
friability, disintegration time, dissolution test etc. This also includes the physiochemical
properties of the active ingredients and excipients as well as the procedures used in the
manufacturing process [9]. The parameters which we include in our study are weight variation,
hardness, friability and disintegration. Disintegration is the break down process of tablet into
smaller particles and is the first step towards dissolution. Hadness effect disintegration of tablets.
It depend upon the presence of disintegrate [10]. The hardness of tablet, binder, lubricant effect
the disintegration time [10]. Faster disintegration of tablets delivers a fine suspension of drug
particles resulting in a higher surface area and faster dissolution [3]. The weight variation,
hardness, friability and disintegration time are important factor for good manufacturing practice
(GMP [5]. In 2012, a comparative In-vitro analysis of different brands of paracetamol in Pakistan
was evaluated for their physical, chemical parameters. In-vitro test like disintegration, friability,
hardness, dissolution was perform & found to be verifying for each tablet but within the specified
limit [7]. In 2012, a in-vitro comparative valuation of quality control paracetamol/caffien tablets
available in bangladesh and conclude that the standard quality control parameter always should be
maintenaid not only for paracetamol or its combination but also for all kinds of medicine for
getting better drug product [8] . In 2012, comparative study of four different brands of
acetaminophen was also conducted and concluded that all four brand varying with each other but
they all comply within the limit [11]. The present study is designed to evaluate the in-vitro
comparative study of three different brand of Paracetamol which include Panadol, Calpol and
Febrol having same strength of 500 mg. for invitro study the disintegration test is selected .
disintegration test was used to determine the time required for tablet to disintegrate.
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October Issue
1458
RESEARCH ARTICLE
Maria Ayub et.al / IJIPSR / 3 (10), 2015, 1457-1462
Department of Pharmaceutics
ISSN (online) 2347-2154
Figure 1: chemical structure of Paracetamol
MATERIALS AND METHODS
We have purchased different brands of Paracetamol (USP) of 500 mg from the local market i.e.
Panadol, Calpol and Febrol. Different quality control testing was performed to compare all three
brands with each other.
Weight variation and average weight:
Six tablets were selected from each of the brand and weighed individually using Electronic
Balance FX-400. Note down the weight of each tablet on sheet in mg. Calculate average weight
in mg.
Hardness:
There is no official limit specified in USP, BP or any other Pharmacopeia. Hardness or crushing
strength were checked on 6 tablets of each brand using Hardness Tester MH-1,Galveno Scientific.
Place tablets one by one and when the device was started, gradually applied force onto the tablet
until it split, and the force at which the tablet split was recorded in Newton.
Disintegration test:
The standard disintegration time for USP uncoated tablet must be as low as 5 minutes but
majority of the tablets have a maximum disintegration time of 30 minutes [13].The method
specified in the USP/NF (1980) was used Disintegration Tester- USP, Electro lab: ED- 2L). The
volume of disintegration medium used was 100ml of water and the temperature was maintained at
37±1°C throughout the experiment for each tablet of all the brands. Six tablets of each brand were
selected and placed in each of the cylindrical tubes of the basket and the disc was used. The time
taken to break each tablet into small particles and pass out through the mesh was recorded [12].
Friability:
Ten tablets for each brand were initially weighed and transferred into Friabilator FB-400 one by
one. The friabilator was operated at 25 rpm for 4 minutes (up to 100 revolutions). The tablets
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RESEARCH ARTICLE
Maria Ayub et.al / IJIPSR / 3 (10), 2015, 1457-1462
Department of Pharmaceutics
ISSN (online) 2347-2154
were weighed again and the calculate the friability in %. NMT 1% is the official limit. %
Friability=Initial Weight(IW) - Final Weight(FW) / Initial Weight(IW) .
RESULT AND DISCUSSION:
Table 1: Parameters of three brands of Paracetamaol
S.no
1
2
3
4
5
6
7
8
9
10
11
12
13
14
15
16
17
18
BRAND
Disintegration
PANADOL 126
120
120
132
138
131
CALPOL
84
81
79
85
78
80
FEBROL
21
20
20
23
25
22
Hardness
131
130
132
133
130
115
90
85
87
86
89
85
102
100
101
97
95
98
Weight variation
583
601
580
600
595
610
610
600
602
605
604
601
571
575
579
580
573
572
Friability
0.4
0.4
0.4
0.4
0.4
0.4
0.45
0.45
0.45
0.45
0.45
0.45
0.29
0.29
0.29
0.29
0.29
0.29
We conduct the comparative study of three different brand of paracetamol namely Panadol,
Calpol and Febrol.. After testing selective parameters it was check for missing values and
inconsistence. Data was analyzed in statistical package for social science (Spss) version 19.The
frequency of sample is six. It was checked for Quality and Validity. Appropriate Statistical
analysis, frequency and percentage were used, while one way ANOVA test was use to observe the
comparative analysis between all these brands with each other. The physicochemical parameters
of different brand of paracetamol tablet 500mg were analyzed. The result of weight variation,
friability, hardness and disintegration were shown in Table-1 and Figure 2. The According to USP
requirement of weight variation not more than 2 tablets. Different in weight between three brands
is due to non-uniformity, uniformity serve as an indication to amount of active pharmaceutical
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RESEARCH ARTICLE
Maria Ayub et.al / IJIPSR / 3 (10), 2015, 1457-1462
Department of Pharmaceutics
ISSN (online) 2347-2154
ingredient i.e. paracetamol enclosed in the formulation as well as Good manufacturing practices
(GMP).The hardness and disintegration time of all three brand were different with each other but
met USP specification. According to USP it should be not more than 30 min. Disintegration time
of Febrol is less as compare to calpol and panadol . The friability of all three brands of
paracetamol tablet vary with each other but within specified limit i.e. NMT 1%.
The results of selected brand are vary with each other but within specified USP limit. Using spss
19.0 version applying one way Anova shows significant result between all three brand i.e.
panadol, calpol and febrol. Its mean the value of p > 0.05 (C.I. 95 %).
Figure 2: Comparative study of three different brands
CONCLUSIONS
It is concluded that the results of all the tests (weight variation, disintegration ,hardness,
Friability) of selected brands of Paracetamol tablet (500mg) exhibit some differences, but these
variations are within the specified limits.
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Maria Ayub et.al / IJIPSR / 3 (10), 2015, 1457-1462
Department of Pharmaceutics
ISSN (online) 2347-2154
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