Abstract

POST MARKET IN-VITRO QUALITY CONTROL EVALUATION FOR DIFFERENT BRANDS OF PARACETAMOL TABLETS AVAILABLE IN INDIAN MARKET

Kaustubh Jagtap*, Bharatee Chaudhari, Aishwarya Jadhav and Vivekkumar Redasani

ABSTRACT

Paracetamol scientifically known as acetaminophen is quite popular over-the-counter (OTC) form of analgesic and antipyretic. It is widely used in most of the countries. Acetaminophen is active metabolite of phenacetin. Chemically, it is 4-hydroxy acetanilide (acetaminophen). Paracetamol has medical uses such as it is commonly used for the relief from headache, minor pains, aches and is a major ingredient in numerous cold and flu remedies. It can be used in all ages of people for reducing fever. The main objective of this case study is to check and compare the quality of marketed finished product of paracetamol tablet formulation which are locally and commonly available in Indian pharmaceutical market manufactured by various pharmaceutical companies as India is one of the biggest pharmaceutical product producers in the world. This study includes the randomly selected four different brands (A, B, C, D) as Calpol 500, Pyrigesic, Pacimol 500 and Febrex of paracetamol conventional tablets of 500 mg strength of active pharmaceutical ingredient of paracetamol from local medical pharmacy stores. These different brand tablets were compared by the in-vitro test accordingly the test procedure given in IP and USP standards and unofficial test standards which are also integral part of this quality control tests. The test parameters for quality assessment and evaluation of tablets are weight variation i.e., weight uniformity, friability, hardness, disintegration time and drug assay content by UV spectrophotometer were performed as per standard of pharmacopoeias. The results are then formed according to the limit ranges of pharmacopeial standards.

Keywords: Paracetamol, Quality Control, Weight Variation, Disintegration Time, Drug Assay.