Alsaifi et al.

Universal Journal of Pharmaceutical Research

Available online on 15.9.2018 at http://ujpr.org

Universal Journal of Pharmaceutical Research
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©2018, publisher and licensee UJPR, This is an open access article which permits unrestricted non commercial
use, provided the original work is properly cited
Volume 3, Issue 4, 2018

RESEARCH ARTICLE

QUALITY ASSESSMENT OF DIFFERENT BRANDS OF PARACETAMOL

TABLETS IN YEMENI MARKET
Abdulmajed Alsaifi1*, Ali Alyahawi2
1
Department of Chemistry, Sana’a University, Republic of Yemen.
2
Department of Pharmacy, Al-Razi University, Republic of Yemen.

ABSTRACT
Paracetamol or acetaminophen is active metabolites of phenacitin. It is a widely used over-the-counter analgesic and antipyretic.
Chemically, it is 4-hydroxy acetanilide (acetaminophen). Paracetamol is approved for reducing fever in people of all ages. It is
commonly used for the relief of headaches, other minor aches and pains, and is a major ingredient in numerous cold and flu
remedies. Many different brands and dosage forms of paracetamol are available in Yemeni market that places health practitioners
in a dilemma of drug substitution in case of non-availability of a particular brand. The aim of the present study was to evaluate the
quality control of four brands of paracetamol tablets (500 mg) marketed and commonly prescribed in Yemeni market. The results
and findings of the present study will be interpreted and discussed. Four brands of paracetamol tablets (500 mg) were purchased
from the retail pharmacy outlets and their pharmaceutical quality were assessed by using in-vitro tests according to USP and BP
standards and unofficial standards as recommended by the manufacturers. The assessment of tablets included the evaluation of
uniformity of weight, hardens, friability, disintegration time, dissolution test as well as assay content by UV spectrophotometric
method. All brands passed USP and BP standards in- vitro quality control tests prescribed for the tablets except hardens test but all
products were satisfactory for hardness. The results indicated that the overall quality of all tested paracetamol tablets brands was
satisfactory as they met the requirements of the official and unofficial quality control tests.
Keywords: Dissolution, disintegration, friability, hardness, paracetamol, quality control.

Article Info: Received 10 August 2018; Revised 29 August; Accepted 5 September, Available online 15 September 2018
Cite this article-
Abdulmajed Alsaifi, Ali Alyahawi. Quality assessment of different brands of paracetamol tablets in Yemeni
market. Universal Journal of Pharmaceutical Research. 2018; 3(4): 42-47.
DOI: https://doi.org/10.22270/ujpr.v3i4.182
Address for Correspondence:
Abdulmajed Alsaifi, Department of Chemistry, Sana’a University, Republic of Yemen.
E-mail: a_majedalsaifi@yahoo.com.

INTRODUCTION by others4, while most sources implicitly distinguish

them, for example by mentioning both NSAIDs and
Paracetamol or acetaminophen is active metabolites of
paracetamol in the same sentence5,6. Paracetamol has
phenacitin (Figure 1). It is a widely used over-the-
few anti-inflammatory effects in comparison to
counter analgesic and antipyretic. Chemically, it is 4-
NSAIDs.
hydroxy acetanilide (acetaminophen)1.
H
Paracetamol is available in different dosage form:
N tablet, capsules, drops, elixirs, suspension and
suppositories. Dosage form of paracetamol and its
combinations with other drugs have been listed in
O various pharmacopoeias7,8.
HO
Quality of the drug according to the modern definition
Paracetamol requires that the product contain the quantity of each
Figure 1: Chemical structure of Paracetamol
active ingredient claimed on its label within the
Paracetamol is approved for reducing fever in people
applicable limits of its specifications, contain the same
of all ages. It is commonly used for the relief of
quantity of active ingredient from one dosage unit to
headaches, other minor aches and pains, and is a major
the next, be free from extraneous substances, maintain
ingredient in numerous cold and flu remedies2.
its potency, therapeutic availability and appearance
It is classified as a non-steroidal anti-inflammatory
drug (NSAID) by some sources3, and not as an NSAID

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Alsaifi et al. Universal Journal of Pharmaceutical Research

until used, and upon administration release active Tablet Disintegration

ingredient for full biological availability9. It was performed using Electro Lab disintegration
Poor quality medicines do not meet official standard apparatus, 6 tablets were placed in disintegration test
for strength, quality, purity, packaging and labeling10. apparatus. It was maintained at 37 ± 0.2 oC containing
Most researchers investigating stated content of simulated gastric fluid (0.1N HCl). Noted down the
paracetamol have utilized HPLC assay that was used as time taken for tablets to disintegrate.
an accurate, simple, reproducible and sensitive method Dissolution Test
for the determination of paracetamol in tablet For this test USP Type-1 (Basket) 6 Paddle Apparatus
formulation11. was used. The tablets formed were immersed into 900
UV-Visible spectrophotometry is one of the most mL. of dissolution medium, simulated gastric fluid
frequently employed technique in pharmaceutical (0.1N HCl). The temperature of the dissolution
analysis. It involves measuring the amount of medium was maintained at 37 ± 0.2oC. The basket was
ultraviolet or visible radiation absorbed by a substance rotated at a speed of 150 rpm. After an interval of
in solution. Instrument which measure the ratio, or every 10 minutes, 2 mL. of the medium was pipette out
function of ratio, of the intensity of two beams of light and replaced with fresh medium (0.1N HCl). This was
in the U.V-Visible region are called Ultraviolet-Visible continued all along for one hour. The pipetted out
spectrophotometers12. samples were then diluted to 10 mL. with fresh
In present study a quality control for a Paracetamol dissolution medium and were then filtered. The
from different manufacturing sources in Yemeni absorbances of the filtered samples were determined
market was investigated. using U.V. Spectroscopy at λ max 222 nm. According
to USP specifications not less than 80% (Q) of the
MATERIALS AND METHODS labeled amount of acetaminophen is dissolved within
This study is based on the comparison of available 30 minutes13.
paracetamol 500 mg tablets brands in Yemeni market Paracetamol Assay
that are available for consumer use. Four brands of Weigh and powdered 20 tablets accurately a quantity
drug were taken that are coded accordingly as A, B, C, of powder equivalent to 0.15 gms of paracetamol and
and D (Table 1), and assessed using the quality control 50 mL of 0.1M NaOH, diluted with 100 mL of water,
parameters of weight uniformity, hardness, friability, shacked for 15 minutes and add sufficient water to
disintegration time, dissolution profile and active produce 200 mL mixed and filtered and diluted 10 mL
ingredient content. The labeled shelf life of all of the of filtrate to 100 mL with water. To 10 mL of resulting
tablets was three years from the date of manufacturing solution add 10 mL of 0.1 M NaOH dilute to 100 mL
and was taken for the evaluation before two years of with water and measure the absorbance of the resulting
the labeled expiry date. The evaluation was done solution at about 257 nm. Assay content for
according to USP and British pharmacopoeia (BP) paracetamol was carried out by measuring the
standards. absorbance of the sample at 257 nm using Shimadzu
Various analytical methods and tests are important for 1240 UV visible spectrophotometer, Japan and
the development and manufacture of pharmaceutical comparing the content from a calibration curve
formulations. The evaluation was done according to prepared with standard paracetamol in the same
USP and BP standards. medium. An accurately weighed quantity of this
Weight Variation powder was taken, suitably dissolved in pH 5.8
Tablets of each brand were weighed individually using phosphate buffer, making dilution and analyzed and
a digital analytical balance Shimadzu. The percentage carried out in triplicate and mean was taken. The
deviation of the individual tablets from the mean was concentration of each sample was also determined
determined according to USP. using Beer Lambert’s law according to BP14.
Hardness Test Data processing and analysis
A tablet was placed vertically on the Monsanto After the completion of all test procedures data for all
Hardness tester. The load was then applied along the the individual tablets were recorded and separated on a
radial axis of the tablet. The weight or load required for different sheets according to the manufacturer. Finally
breaking the tablet was noted down. Similarly it was data were analyzed by using the above mentioned
done for 10 tablets. mathematical formula and MS-Excel®, 2007.
Friability
It was performed using Roche Friabilator, 10 tablets RESULTS AND DISCUSION
were weighed and placed in apparatus. The apparatus During this research standard books and procedure
was rotated at a speed of 25 rpm. The apparatus was were used to conduct each test. Among the books BP 15
made to rotate for 4 min. The tablets were then and USP16 were widely used. The degree of tolerance
weighed and the weights were compared with the was also taken from the two pharmacopeias. A total of
initial weights. The % friability was calculated using 6 Paracetamol brand marketed in Somali region were
the formula. screened for weight variation, friability, disintegration
Wo − W time, identification and content uniformity.
%F= X100
Wo Average Weight and Weight Variation
Where, % F = Friability in %, Wo = Initial weight of The average weight and weight variation of the
tablets, W=Weight of the tablets after revolution. different brands of paracetamol tablets tested are
shown in Table 2 and Figure 2. It was found that the

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Alsaifi et al. Universal Journal of Pharmaceutical Research

average weight of different four brands tablets of Friability Test

paracetamol ranged from 566.30.912 to 668.380.944 Friability is another important parameter that is related
mg. According to official books, the specified limit on to hardness, disintegration and dissolution. The average
weight variation for tablets more than 324 mg is ± 5%. values of friability of the different brands of
It was found that all the tablets passed the USP paracetamol tablets tested are shown in Table 3 and
specifications for weight variation as none of the Figure 5. The results indicated that the entire tablet
brands deviated by upto ±5% from the mean value. samples tested showed impressive friability values
This indicates that the factors leading to weight ranging from 0.063 % (A brand) to 0.22 % (D brand).
variation were taken in consideration. Also, the very According to the USP18 the allowed limit of friability is
small %RSD values of weight variation prove the high not more than 1.0 % of weight Loss. In all formulations
homogeneity of the tablets produced and shown high the percent (%) friability was less than 1% and as such
efficiency of weight uniformity and weight all the brands of paracetamol had passed this friability
distribution. Weight variation gives a rough idea of specification. This indicated that all the tablets of each
content uniformity, but not a confirmatory test. On the brand were mechanically stable24.
other hand, there were differences in the weight of Disintegration Time
tablet even though all tablets contain 500 mg active. A Tablet disintegration time is one of the very important
possible explanation for this might be that different physicochemical properties in solid dosage forms. The
excipients used for the manufacturing which are disintegration test measures the time required for
increasing or reducing the weight of the tablet17. tablets to disintegrate into particles. This is a necessary
Content Uniformity (Assay) condition for dissolution and could be the rate-
Test for percentage of content is based on the assay of determining step in the process of drug absorption. The
the individual content of active ingredient of a number average values of disintegration of the different brands
of single dose units. The average chemical content of paracetamol tablets tested are shown in table 3 and
(assay) values of the different brands of paracetamol figure 6. The highest disintegration time (14.10 min)
tablets tested are shown in table 2 and Figure3. The was observed for B brand, while the lowest
results of the assay of chemical content of paracetamol disintegration time (2.00 min) was observed for A
tablets showed that the active content of all the brands brand. That is, a brand quickly disintegrated compared
were between 97.25 % (B brand) and 99.15% (D to other brands, with disintegration time of 2.00 min.
brand) of the labeled amount specified for paracetamol. The result showed that disintegration time of all the
According to the United State Pharmacopoeia18, a selected tablets was found to be within specified limits
paracetamol tablet should contain not less than 90% of USP and BP. According to BP25, which specifies 15
(450 mg) and not more than 110% (550 mg) of minutes as disintegration time whereas uncoated USP
paracetamol. The results indicated that although tablets have disintegration time standards as low as 5
different manufacturer formulates the different brands minutes. All brands met the requirements for
are under the BP/USP specification19. The results disintegration test.
indicated that although different manufacturer Dissolution Test
formulates the different brands are under the BP/USP Dissolution was another studied important quality
specification19. There was no statistically significant control parameters directly related to the absorption
difference between the different brands of the and bioavailability of drug. Also, dissolution
paracetamol tablets. Furthermore, all the brands of the behaviour of a drug has a significant effect on their
tablets passed the test for the content of paracetamol. pharmacological activity. In fact, a direct relationship
Hardness between in vitro dissolution rate of many drugs and
In the pharmaceutical industry, hardness of the tablets their bioavailability has been demonstrated and is
is an important parameter because pharmaceutical generally referred to as in vitro – in vivo correlation26.
tablets must have sufficient ability to survive the Drugs with poor dissolution profile will not be
handling forces during packaging and shipping. The available in the body system or target organ/tissue to
average values of hardness of the different brands of elicit therapeutic effect. The average values of
paracetamol tablets tested are shown in Table 2 and dissolution of the different brands of paracetamol
Figure 4. The results indicated that, the average values tablets tested are shown in table 3 and figure 7. Tablet
of hardness of the different brands of paracetamol dissolution in 30 minutes ranged from 95.5 % to
tablets tested were in the range 13.67 kg/cm2 – 26.075 101.58 %. All brands of showed more than 90 % drug
kg/cm2. In the study, all brands of paracetamol tablets release after 30 minutes. Dissolution of the all the
were above the limit range of between 4 to 10 kg/cm2 selected brands of paracetamol tablets was found to be
stated20,21. High crushing strength is attributed to a high within the specified limits of not less than 80 % in 30
compression force, high binder concentration or excess min (USP)18 and not less than 70% (BP)14. All brands
volume of granulating fluid22. This related to one or of paracetamol tablets achieved this standard. This
combined factors affect on hardness. Although all might be as a result of strict adherence to good
uncoated brands of paracetamol tablets have very high manufacturing practice in the process of manufacturing
hardness, they still exhibited very good quality control these tablets.
parameters such as dissolution profile, disintegration
time and chemical content determination. This CONCLUSION
indicates that hardness test is not a critical quality The in-vitro physical and chemical evaluation of
control parameter23. selected commercial brands of paracetamol available in

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Yemeni market proved the quality and efficacy 8. The United States Pharmacopoeia. U.S. Pharmacopeial
according to the standards of USP and BP Convention, Rockville, MD 2000, 24th revision, 17-39.
requirements. Paracetamol is a prescription drug, 9. Banker GS. Drug Products: Their role in the treatment of
disease, their quality and their status and future as drug-
Hence, it is essential that it is manufactured following delivery systems In GS Banker, CT Rhodes (Eds) Modern
Good Manufacturing Practice (GMP). In this study, it pharmaceutics. New York: Marcel Dekker, Inc. 2002; 1-21.
was observed that all the formulation complied with 10. Liya T, Esubalew A, Ayenew A. Quality evaluation of
the specification. It is also important that the tablets paracetamol tablets obtained from the common
meet all the parameters because all are essential. All shops (Kiosks) in addis ababa, Ethiopia. Int J Pharm sci res.
four brands of the paracetamol tablet comply with BP 2014; 5(8): 3502-3510.
11. Osama IG Khreit, Hanan AM Alkailani, Wala SK Alqathaf.
and USP specifications for in vitro quality control tests A comparative study of physical and chemical parameters of
of uniformity of weight, uniformity of content, selected paracetamol tablets available in the pharma market
friability, disintegration time, and dissolution except of Libya. Der Pharma Chemica. 2017; 9(2):1-6.
hardens test (see table 3.3). The USP and BP 12. Behera S, Ghanty S, Ahmad F, Santra S, Banerjee S. UV-
specification of maximum hardens value of 10 kg/cm2, visible spectrophotometric method development and
where the lower value of hardens is 13.67 kg/cm2 and validation of assay of paracetamol tablet formulation. J Anal
Bioanal Techniques. 2012; 3:6.
the value is 26.075 kg/cm2. But Hardness is referred to
13. US Pharmacopoeia. The Official Compendia of Standards. 2,
as non-compendial test. 2007; 1269-90.
If the hardness is increased, then the disintegration rate 14. British Pharmacopoeia. H. M. Stationary office, London, 3,
will increase and this will affect the dissolution profile. 2008; 2968.
It is also necessary that the drugs disintegrate properly 15. British Pharmacopeia (BP). Vol. II, Her Majesty’s Stationary
because this will influence the dissolution profile. Office, London. 2001
Pharmaceutical equivalence can also be determined 16. US Pharmacopoeia National Formulary, USP 23/NF 18,
United States Pharmacopoeial Convention. Inc., Rockville,
from these tests. According to my knowledge, not MD, 1995.
much work has been done to determine the quality 17. Abdullahu B, Lajçi A, Shehu V, Krasniqi S, Islami H. Med
control parameters of generic paracetamol tablet Arh. 2010; 64(4):196-198.
available in market. So further study needs to be 18. United States Pharmacopoeia and National Formulary (USP
conducted regarding the quality control parameters 30-NF 25). United States Pharmacopoeial Convention, 2007.
because paracetamol is widely used by people and it is 19. United State Pharmacopoeia (USP 28/NF 23, 2005). United
State Pharmacopeial Convention INC., Rockville, 183-184.
necessary that the product is of good and acceptable
20. Musa H, Sule YZ, Gwarzo MS. Assessment of
quality. physicochemical properties of metronidazole tablets
marketed in Zaria, Nigeria. Int J Pharm Pharm Sci. 2011; 3
CONFLICT OF INTEREST (Suppl 3): 27-29.
The authors declare that they have no competing 21. Lachman L, Liberman Herbert A, Kanig Joseph L. “The
interests. theory and the practices of industrial pharmacy” third
edition, fourth Indian reprint 1991. Varghese Publishing
house, Hind rajasthan building, Dadar, Bombay.
REFERENCES 22. Ibezim EC, Attama AA, Obitte NC, Onyishi VI, Brown SA.
1. Amit KN. Comparative in vitro dissolution assessment of In vitro prediction of in vivo bioavailability and
some commercially available paracetamol tablets. Int J bioequivalence of brands of metronidazole tablets in Eastern
Pharm Sci Rev Res. 2010; 2(1): 29-30. Nigerian drug market. Scientific Research and Essay. 2008;
2. Acetaminophen. The American Society of Health-System 3(11), 552-558.
Pharmacists. Retrieved 3 April 2011. 23. Adegbolagun OA, Olalade OA, Osumah SE. Comparative
3. Keith H, Derek WJ, Andrew R. Medical pharmacology and evaluation of the biopharmaceutical and chemical
therapeutics. Philadelphia: W.B. Saunders. 2001;310 equivalence of some commercially available brands of
4. Acetaminophen. Chemicall and 21.com. Retrieved January ciprofloxacin hydrochloride tablets. Trop J Pharm Res. 2007;
2011. 6 (3):737-745.
5. Viswanathan AN, Feskanich D, Schernhammer ES, 24. Kalakuntla R, Veerlapati U, Chepuri M, Raparla R. Effect of
Hankinson, SE. Aspirin, NSAID, and Acetaminophen Use various super disintegrants on hardness, disinte-gration and
and the Risk of Endometrial Cancer. Cancer Res. 2008; 68 dissolution of drug from dosage form. J Adv Sci Res. 2010;
(7): 2507. 1(1): 15-19.
6. Altinoz MA, Korkmaz R. NF-kappa B, macrophage 25. British Pharmacopoeia, UK London, Appendix IIB. 2007,
migration inhibitory factor and cyclooxygenase-inhibitions 1678
as likely mechanisms behind the acetaminophen- and 26. Tousey MD. Tablet pro: A tablet making training resource
NSAID-prevention of the ovarian cancer Neoplasma. 2004; for tablet making professionals. Techceuticals. 2011; 4(1):1-
51 (4): 239-47 15.
7. Reynolds JEF. Martindale The Extra Pharmacopoeia",
Pharmaceutical Press, London. 1996; 31:27-28.

Table 1: Different brands of Paracetamol tablets.

Code Dosage form Country of origin Batch no.
A Tablet Ireland 120979
B Tablet Egypt 122378
C Tablet U.A.E 1822
D Tablet U.A.E 2909

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Table 2: Average weight, % deviation from average weight, content uniformity, % deviation from content
uniformity, hardness (kg/cm2) and % deviation from hardness of different brands of paracetamol tablets.
Brands Average weight (mg) , Content uniformity (%), Hardness (kg/cm2) ,
% RSD % RSD % RSD
A 668.38 ± 0.944 98.3 % ± 2.52 13.67 ± 2.44
B 613 ± 0.498 97.25 % ± 1.26 26.075 ± 13.33393
C 640.79 ± 0.616 98.2 % ± 0.44 19.57 ± 2.348
D 566.3 ± 0.912 99.15 % ± 0.966 15.765 ± 8.506

Figure 2: Comparison of different brands weight variation of different brands of paracetamol tablets.

Figure 3: Comparison of assay content (Percent %) of different brands of paracetamol tablet.

Figure 4: Comparison of hardness of different brands of paracetamol tablet.

Table 3: Friability percent (%), disintegration time (min), dissolution (30 min), % deviation from dissolution
of different brands of paracetamol tablet
Brand Friability Disintegration Dissolution (min),
(%) time (min) % RSD
A 0.063 2.00 101.58 % ± 1.21
B 0.18 14.1 95.5 % ± 0.980
C 0.153 3.00 98.18 % ± 0.798
D 0.22 3.35 100.52 % ± 2.863

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Figure 5: Comparison of friability percent (%) of different brands of paracetamol tablet.

Figure 6: Comparison of disintegration time (min) of different brands of paracetamol tablet.

Figure 7: Comparison of dissolution test of different brands of paracetamol tablet.

Table 4: Summary evaluation test of different brands of paracetamol tablets

Brands Weight Assay content, %, Hardness, Disintegration Dissolution, %
uniformity (mg), %RSD kg/cm2 , %RSD Friability (min) (30 min)
%RSD (%)
A 668.38 (±0.944) 98.3 (±2.52) 13.67 (±2.44) 0.063 2.00 101.58 (±1.21)
B 613 (±0.498) 97.25 (±1.258) 26.075 (±13.334) 0.18 14.1 95.5 (±0.980)
C 640.8 (±0.6157) 98.2 (±0.44) 19.57 (±2.348) 0.153 3.00 98.18 (±0.798)
D 566.3 (±0.912) 99.15 (±0.966) 15.765 (±8.506) 0.22 3.35 100.52 (±2.863)

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