Abstract

IN- VITRO EVALUATION OF SOME BRANDS OF ACETYLSALICYLIC ACID AND DICLOFENAC TABLETS COMMERCIALLY AVAILABLE IN BENIN CITY METROPOLIS, EDO STATE, NIGERIA

Johnbull Aiwaguore Obarisiagbon* and Isaac Olatunde Awonyemi

ABSTRACT

The quality of a medicinal product is paramount to ensure the safety of the patients, the decisive delivery of the drug(s) to its site(s) of action and to favourably achieve its clinical effect when administered. Many variables of quality assurance of pharmaceutical product are used which can guarantee the quality, bioavailability and optimal therapeutic activity. The aim of this research therefore, was to assess the quality of some commercially available brands of Acetylsalicylic acid (aspirin) and Diclofenac sodium tablets dispensed in pharmacies and other health institutions in Benin City metropolis, Edo State, Nigeria. The organoleptic and physicochemical properties of these brands of the two pharmaceutical products were assessed in accordance to British Pharmacopoeia (BP) and United State Pharmacopoeia (USP) and other unofficial standards as specified by manufacturers. The parameters measured were weight variation, diameter/thickness, hardness, tensile strength, friability, content uniformity by High pressure liquid chromatography (HPLC) analysis, disintegration time and dissolution rate profile. The results indicate that all the 5 brands of Acetylsalicylic acid tablets passed the weight variation test, disintegration test (2.56 – 12.55 min - the limit being 15 min for uncoated tablets and the dissolution test (% drug released for the 5 brands > 70% in 45 min). Similarly, all the 6 brands of Diclofenac sodium tablets passed the weight variation test, disintegration test (1.67– 27.00 min – the limit being 30 min for coated tablets) and dissolution test (% drug released for the six brands > 70% in 45 mins). The tablets of the different product brands passed the hardness test as none was less than 4 kg, and friability test (≤ 1%). The mean percentage drug content of acetylsalicylic acid tablets range from 90.60 – 100.20%; while those of diclofenac sodium tablets range from 90.12 – 100.6% respectively. Based on the population of samples studied of acetylsalicylic acid and diclofenac sodium tablets respectively, it can be inferred that most of the pharmaceutical drug products are of sound standards of quality. Nevertheless, drug monitoring agencies and law enforcements personnel are required to keep adequate surveillance on manufacturers, various seas and land boarders to ensure that only drugs of sound pharmaceutical qualities are allowed into the country.

Keywords: Aspirin, Diclofenac, HPLC, Dissolution rate.