In-Vitro Evaluation of Different Marketed Brands of Paracetamol Tablets Using Quality Control Tests

 

Abhishek S. Pujari*, Nitin A. Gaikwad, Indrajeet V. Mane, Ganesh B. Vambhurkar, Pravin P. Honmane.

Rajarambapu College of Pharmacy, Kasegaon, Dist – Sangli, Maharashtra, INDIA – 415404.

*Corresponding Author E-mail: abhipujari4048@gmail.com

ABSTRACT:

A lot of suppliers sale the paracetamol tablets as the OTC product among the patients, as a mostly use antipyretic and analgesic agent. Ultimate aim of this research was to compare and evaluate different brands of paracetamol tablets for their performance which are sold in sangli district. Five different brands of the acetaminophen tablets (paracetamol tablets) were randomly collected from the different pharmacy shops present in the sangli district. To perform this experimental work various official books like USP and BP was used to determine the in vitro quality tests using various procedure as well as different analytical tests. In evaluation of different brands of paracetamol tablets we were perform determination of different parameters like weight variation, friability, hardness, drug content, identification test, disintegration time and dissolution profile. By performing weight variation and friability test we were fond that different brands show acceptable value. From UV analysis of different sample we were found that none of the brand contain NLT 95 % of active drug content. Each and every branded tablet taken for comparative evaluation gives different results from each other but no one crosses the limits given in official books.

 

KEYWORDS: Paracetamol, Comparative evaluation, Quality control test, Different brands of paracetamol,

 


INTRODUCTION:

There is competition between pharmaceutical companies to find out new molecules for different ailments. Different pharmaceutical companies formulate the different generic drug formulation under different brand name. Manufacturing of drug substance in small scale is found in India which may widely distribute or marketed locally. Active pharmacological substances for common diseases are available as over the counter. Several Study shows that majority of active pharmaceutical ingredients are used without prescription mostly in rural area. Paracetamol is a widely used over-the-counter analgesic (reliever the pain) and antipyretic (reducer the fever).

 

The chemical structure of acetaminophen (paracetamol) is shown in (Figure.1).

 

Figure 1: Structure of Paracetamol

 

Paracetamol is commonly used for reduce the abnormal increase in body temperature, minor body aches and pains and also used for treatment for cold and flu [1]. Pharmacological effect of the drug substance is depends upon thenumbers of factor such as presence of active pharmaceutical ingredient in labeled amount and its systemic availability. One of the main objectives of the tablet formulation is to deliver drug to human body in appropriate concentration to give pharmacological action. Weight variation, hardness, friability, disintegration time, dissolution profile can have a significant effect on the drug product the quality. Also physicochemical properties of active drug substance and exciepients affects on drug performance. All above mentioned parameters are related to each other and affects on the absorption and bioavailability of drug substance through the gastrointestinal track. The ultimate aim of the study was to evaluate the IPQC tests between tablets of different brands because quality of medicine is depends on the standard quality parameters [2].

 

MATERIAL AND METHODOLOGY:

Chemicals used:

Various chemicals used for research are analytical grade as follows hydrochloric acid and sodium Hydroxide freshly prepared demonized water used throughout the research.

 

Apparatus and Equipments:

Apparatus used during research are UV-Visible Spectrophotometer, Analytical balance, Monsanto hardness tester, Roche friability tester, Disintegration apparatus, Dissolution apparatus, Sonicator, Drying oven.

 

Sample Collection:

To study comparative evaluation different brands of paracetamol five brands of different companies like crocin, calpol-500, p-500, dolo-500 and fepanil-500 were purchased from medical shops within sangli district and coded as A,B,C,D and E respectively. All purchased brands contain 500 mg paracetamol per tablet. All brands are having shelf life three year from manufacturing date and for study tablets are taken which having expiry date two year away from study date (Table 1).

 

Study Design

Different brands of paracetamol tablets were study by determining different parameters like weight variation, hardness, friability, disintegration time, dissolution profile and drug content in vitroly.

 

METHODOLOGY:

For development and evaluation of formulation various analytical methods and tests are important. According to USP and BP standards evaluation was done.

 

Identification Test of Paracetamol:

Different identification tests were conducted according to mentioned in British pharmacopoeias.

 

 

Weight Variation:

Weight of individual tablet of each brand was taken using Analytical balance. Percentage deviation was determined according to USP individually.

 

Hardness Test:

Hardness test was done by using Monsanto Hardness tester by placing tablet vertically on it. Then load was applied and at which load breaking of tablet take place is determined about 10 tablets are used for this test.

 

Friability:

Friability test was done by using Roche Friabilator; about 10 tablets are required for this test. This test was done by keeping 25 rpm rotating speed of apparatus and duration of rotation is about 4 min. After completion of this process tablets were weight and this is compared with the initial weight of tablets. By using % F = [1 - (W/Wo)] x 100 (Where, % F = Friability in %, Wo = Initial weight of tablets, W = Weight of the tablets after revolution) this formula % friability was calculated.

 

Tablet Disintegration:

Disintegration test was performed by using disintegration test apparatus; in disintegration test apparatus 6 tablets were placed. Temperature of medium (simulated gastric fluid (0.1N HCl)) was maintained at 37± 0.2oC.Then time taken for tablets to disintegrate were noted.

 

Dissolution Test:

To perform dissolution USP Type-1 (Basket) 8 Paddle Apparatus was used. Then tablets were put in into the 900 ml of simulated gastric fluid (0.1 N HCl). Experimental condition of dissolution was maintained, like temperature of medium was maintained at 37 ± 0.2oC. Rotation speed of basket was maintained at 150 rpm. Then 2 ml of dissolution medium was pipette out after interval of 10 minutes and sink condition was maintained with fresh medium (0.1 N HCl). This process was continued after every 10 minutes for one hour. Dilution of pipetted sample was carried out by fresh dissolution medium up to 10 ml then this 10 ml medium was then filtered. By using U.V. Spectroscopy at λ max 222 nm. According to USP absorbance was       determined [3].

 

Assay:

To find out difference between the actual amount of active drug and labeled amount assay was done. About 10 tablets of each brand was taken and finely grounded and from this fine powder equivalent to 150 mg paracetamol were put in to 200 ml of volumetric flask in to that 100ml of distilled water and 50 ml of 0.1M sodium hydroxide was added and this mixture was sonicated up to 15 minutes, then formed solution was diluted up to the volume and filtered then into 100 ml volumetric flask 10 ml of filtrate was transferred and diluted up to 100 ml with purified water. Then into the another 100 ml of volumetric flask 10ml of 0.1 M NaOH with 10 ml of filtered solution was transferred and volume is make up with distilled water. The UV spectrophotometer was put ready to take absorbance by running a baseline (200-400nm) with 0.1 M NaOH solution as blank sample. Then absorbance of assay preparation was taken by using λ max 257nm with UV Spectrophotometer and 0.1 M NaOH solution was used as blank solution. Same process was used for150mg pure drug substance (paracetamol) then absorbance of pure drug was determined, this observed absorbance was used to determined the percent content of pure drug into the each brand which was taken. By using Beer Lambert’s law the concentration of each sample was also determined according to BP [4].

 

RESULTS AND DISCUSSION:

The results obtained from five different brands of paracetamole tablets are met the USP and BP standers of IPQC tests within specified limits.

 

Weight Variation:

Weight variation for tablets more than 324 mg is ± 5 % is mentioned in the official books. From evaluation it was found that all taken tablets passed the USP for weight variation none of the taken brand tablet deviated from the mean value by ±5%. We can get rough idea of content uniformity, but we cannot confirm from this test.

 

Friability:

This friability test gives idea about the parameters like hardness, disintegration and dissolution. Not more than 1.0 % of weight Loss is allowed limit for the friability. It may depend up on the nature of binders and additives used in formulation. Friability of each brands are within the limits.

 

Hardness:

Hardness important parameter because in the pharmaceutical industry, because tablet must survive during the packing and shipping. Also tablet not becomes a too hard because hardness is directly affected on the disintegration time, which may decrease the bioavailability [5]. Hardness should be in the limits of 4 kg/cm2 to 10 kg/cm2. Hardness of each branded tablet was within the limits.

 

Disintegration Time:

Disintegration time helps us to determine the dissolution and absorption of active drug substance through the body also on the therapeutic efficacy of product. Result obtained from disintegration study was found to be within specific limits given in standered books like USP and BP [6] (Figure 2), according to these books disintegration time is 15 minutes. Obtained results of disintegration test are given in (Table 2).

 

Assay:

Percentage of content active drug substance i.e. paracetamol was found by assay method. All taken branded tablet shows paracetamol content with in 100 ±10 % of the labeled claim. According to USP and BP paracetamol contents should not be more than 110% and be less than 90 % (Table­ 3).

 

Dissolution;

Dissolution test results obtained from each brand of paracetamol tablet are within the limit specified limits according to USP (NLT 80 % in 30 min) and BP (NLT 70 % in 30 min). Good results was obtained from each brand of paracetamol tablet (Table 4). Hence medication containing paracetamol (analgesic and antipyretic formulation) gives the relief from pain to the patient within short period of time action of drug is depend on the release of the drug [7] [8].

 

Table 1: Manufacturing date and expiry date of different paracetamol brands under test

Tablet Code

Manufacturing date

Expiry date

A

Nov 2017

Sept. 2020

B

Feb 2018

Jan2021

C

Jan 2018

Des 2021

D

Jan 2018

Des 2021

E

Des 2017

Nov. 2020

 

Table 2: Comparative evaluation of different quality control parameters of paracetamol tablets

Tablet Code

Weight Variation %

Friability %

Hardness (kg/cm2)

Disintegration Time (Min.)

A

0.8

0.37

5.0

3.2

B

1.9

0.46

4.6

2.9

C

0.7

0.50

4.8

3.1

D

1.2

0.56

4.5

2.4

E

1.5

0.40

4.3

2.5

 

Table 3: Result obtained for percent content of paracetamol tablets by UV method

Tablet Code

Concentration (mg/ml)

Absorbance

% Content

Content (mg)

A

0.000652

0.530

103.59

510.95

B

0.000569

0.495

95.00

475.00

C

0.000602

0.500

97.73

488.65

D

0.000600

0.510

99.62

498.10

E

0.000598

0.486

95.01

475.05

 

Table 4: Comparative evaluation of dissolution profile of paracetamol tablets

Time interval (Minutes)

% Release of Paracetamol content

A

B

C

D

E

10

71.15

75.68

70.92

59.00

65.44

20

79.50

86.32

89.65

70.15

74.69

30

95.00

91.65

94.08

78.45

82.54

40

99.50

96.10

97.22

89.59

93.89

50

95.77

99.03

99.30

97.39

90.01

60

92.03

95.40

94.00

94.87

87.95

 

Figure 2: disintegration time (Min.) of different brands of Tablet

 

 

 

 

Figure 3: assay of different brands of paracetamol tablets

 

 

 

Figure 4: dissolution profile of different brands of paracetamol tablet

CONCLUSION:

From the obtained result we were conclude that each and every branded tablet taken for comparative evaluation gives different results from each other but no one crosses the limits given in official books.

 

ACKNOWLEDGEMENT:

Authors are highly Acknowledge the help of laboratory staff of Rajarambapu College of Pharmacy, Kasegaon. For providing necessary chemicals required for research work. Also we are highly Acknowledge the help and guidance of Dr. M. A. Bhutkar

 

REFERENCES:

1.     Tripathi KD: Essential of Medicinal Pharmacology. Jaypee Brothers, Medical Publishers Ltd. Dehli, Fifth Edition.

2.     Palash Karmakar, Md. Golam Kibria: In-vitro comparative evaluation of quality control parameters between paracetamol and paracetamol/caffeine tablets available in Bangladesh. International Current Pharmaceutical Journal 2012; 1(5):103-109.

3.     US Pharmacopoeia, The Official Compendia of Standards, 2, 2007, 1269- 90.

4.     British Pharmacopoeia, H. M. Stationary office, London, 3, 2008, 2968.

5.     US Pharmacopoeia, 28 (30-NF25), 2007, 618-690.

6.     L. Allen, Ansel’s Pharmaceutical Dosage form and Drug Delivery System. Lippincott Williams and Wilkins, Wolters Kluwer health, 9, 233.

7.     British Pharmacopoeia, UK London, Appendix IIB, 2007, 1678.

8.     Bamigbola, E.A., Ibrahim, M.A., Attama, A.A. 2009. Comparative in-vitro assessment of soluble and plain brands of aspirin tablets marketed in Nigeria, Sci Res Essays, 11(4), 1412-1414.

 

 

Received on 19.06.2018                Accepted on 28.07.2018               

© Asian Pharma Press All Right Reserved

Asian J. Pharm. Tech.  2018; 8 (3):119-122 .

DOI: 10.5958/2231-5713.2018.00019.3