POST-MARKETING QUALITY ASSESSMENT OF GENERIC ROSUVASTATIN TABLETS IN ADEN-YEMEN

Abstract

The increasing availability of generic Rosuvastatin (ROS) tablets necessitates rigorous post-marketing quality evaluation, particularly in regions with limited regulatory oversight, such as Yemen. This study aimed to assess the pharmaceutical quality and in vitro performance of commercially available ROS (20 mg) tablet brands in the Aden market. Five ROS brands were evaluated using validated high-performance liquid chromatography (HPLC) and pharmacopeial quality control tests in accordance with USP/BP guidelines. Parameters assessed included weight variation, hardness, friability, disintegration time, and dissolution. Dissolution testing was conducted at pH 6.6 following FDA recommendations due to the acid instability of ROS. The HPLC method demonstrated excellent linearity (R² = 0.9993), with assay values ranging from 92.01% to 108.45%, complying with pharmacopeial limits. All brands met requirements for weight uniformity, friability, and disintegration. Although TAB.3 and TAB.4 exhibited higher hardness values (20.22 and 18.3 kg/cm²), this did not adversely affect their performance. Dissolution studies showed that all brands released more than 80% of the labeled drug within 30 minutes, with most exceeding 85%, indicating rapid dissolution. TAB 1 showed a lower mean dissolution of 75.99% at the 30-minute time point. All evaluated ROS brands demonstrated acceptable pharmaceutical quality and in vitro performance, supporting their potential interchangeability. However, variability in dissolution behavior among certain brands highlights the importance of continuous post-marketing surveillance to ensure consistent therapeutic efficacy in the Yemeni pharmaceutical market.