Comparative in vitro dissolution study of Aceclofenac Marketed Tablets in Two Different Dissolution Media by Validated Analytical Method.

ABSTRACT

In this study five marketed brands of aceclofenac 100 mg tablets have been evaluated using dissolution test in two different media with the aim to assess bioequivalence and to select a proper dissolution medium. Other general quality parameters of these tablets like weight variation, hardness, friability, disintegration time were also determined according to established protocols. All the brands complied with the official specification for friability, uniformity of weight, disintegration time and drug content. UV spectroscopic and RP-HPLC methods were validated for the parameters like linearity, accuracy, precision and robustness. Potency was determined by using these two methods. Potency obtained from UV method and HPLC methods were found similar with paired t test. Dissolution test results were subjected to further analysis by difference factor (f1), similarity factor (f2) and dissolution efficiency (% DE). Higher drug release was found in phosphate buffer pH 6.8 than in 0.05% sodium lauryl sulphate solution. All brands were found similar in respect of drug release in phosphate buffer pH 6.8 but they differ in respect of drug release in 0.5% sodium lauryl sulphate. So phosphate buffer pH 6.8 may be a suitable media for dissolution study of aceclofenac tablets.