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Abstract

COMPARATIVE QUALITY EVALUATION OF PARACETAMOL TABLET MARKETED IN AMBALA REGION BY SPECTROPHOTOMETRIC DETERMINATION OF ACETAMINOPHEN CONTENT

Dr. Rekhani Jyoti Pal*, Gulshan Kumar and Preety Kaur

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Abstract

The safety and efficacy of a pharmaceutical dosage form can be guaranteed when its quality is reliable. The quantitative determination of acetaminophen in paracetamol tablets marketed in Ambala by five different manufacturers was done in this study. The efficacy of pharmaceutical dosage forms generally depends on their formulation properties, and manufacturing methods, hence it is likely that the quality of dosage form may vary. The results obtained from the mean percentage analysis of paracetamol tablets (%) containing 500 mg of acetaminophen showed that the mean percentage determined in three replicate analyses is more than the claimed amount by the manufacturers. The study was exclusively experimental that used BP, USP and other standard books to check the in vitro quality of Paracetamol tablet using spectrophotometrically at wavelength (λmax) of 505 nm. Paracetamol with resorcinol gave azodye following Lambert Beer’s law in range of 2-10 μg/ml (r2= 09991) of paracetamol with detection limits of 0.192 μg/ml and 0.640 μg/ml limit of quantification respectively. The method developed by the authors was found to be precise and accurate for qualitative and quantitative determination of paracetamol. The precision was obtained as repeatability; relative standard deviation ranges from 0.53 to 1.37 %, standard error also ranges from 1.41 to 2.49 while standard deviation ranges from 2.78 to 7.22 respectively. The accuracy results of 75 %, 100 %, 125 % by replicate analysis (n = 3) were 101.85 % to 102.35 % respectively. Validation study reveals that the methods are specific, accurate, precise, and reproducible. Validation studies are statistically significant as all the statistical parameters are within the acceptance range (% RSD < 2.0 and S.D. < 2.0) for both accuracy and precision study. High recovery and low % RSD reveals the reliability of the method for quantitative study of three drugs in tablet formulation. The proposed method is simple, rapid, accurate, precise, reproducible and economical and can be used for routine quantitative analysis of paracetamol. Test for weight variation, friability, disintegration time, identification test and assay were conducted. All of the brands under the study were within the specification for weight variation test. But from the contraband brands, two for friability, one for disintegration and all for percentage content paracetamol failed to satisfy the requirement though all of the products contain the weight active ingredients. The regulatory body must work to stop illegal smuggling of medications, rather should focus on use of legal medications.

Keywords: Paracetamol, Acetaminophen, Tablet, UV spectrophotometric method, Ambala region.


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