COMPARISON OF UV SPECTROPHOTOMETRY AND HPLC METHODS FOR THE DETERMINATION OF PHARMACEUTICAL EQUIVALENCE OF CLOPIDOGREL TABLET BRANDS MARKETED IN NIGERIA

S. E. Ukwueze* and C. Uliah

ABSTRACT

A comparative quality control study using ultraviolet (UV) and High performance liquid chromatography (HPLC) spectroscopy was conducted to assess the pharmacopoeial quality and compliance of five brands of commercially available clopidogrel tablets marketed in some Nigerian cities. Physical examination of the brands and information such as batch number, date of manufacture and expiry, producer, country of production, label claim of drug content and registration status with the National Agency for Food and Drug Administration and Control (NAFDAC) were noted. Quality control parameters such as uniformity of weight, friability, crushing strength, total drug content, disintegration time and dissolution profile were all conducted. Results showed that the five brands were all duly registered. The brands contained clopidogrel as their active ingredient and they all met the USP specifications for the total active drug content and other control parameters such as crushing strength, friability, disintegration time and dissolution profiles. Only one brand (CP-3) failed the weight uniformity test. A comparison of the two analytical methods used showed that the HPLC method was more accurate and precise in assessing the total drug content and other related parameters and, as such, should be relied more in quality assurance analysis of drugs when compared to UV. The brands (except CP-3) were, thus, interchangeable and could be prescribed in place of one another in clinical practice.

Keywords: Clopidogrel, Tablet, Quality Assurance, Nigeria, HPLC, UV.