A NEW RP-HPLC METHOD DEVELOPMENT AND VALIDATION FOR THE DISSOLUTION STUDIES OF ATENOLOL AND CHLORTHALIDONE IN IMMEDIATE RELEASE TABLET DOSAGE FORMS

A simple, precise, rapid, specific and accurate reverse phase high performance liquid chromatography method was developed for dissolution studies of Atenolol (ATN) and Chlorthalidone (CTN) in immediate release tablet dosage forms. Dissolution sample was obtained by placing tablets into the USP2 dissolution apparatus (Paddle Type) rotating with 50rpm speed. Water was used as medium and a volume of 900ml of dissolution medium was used. The bath temperature was 38oC and bowl temperature was 37oC. The samples were collected after 45 minutes. Chromatographic separation was performed Agilent C8, 150X4.6, 5µm column, with mobile phase comprising of ammonium acetate buffer: pH 7.00 and methanol in the ratio of 60:40v/v, at the flow rate 1.0ml/min. The detection was carried out at 228 nm. The retention times of ATN and CTN were found to be 2.18 and 3.32 min respectively with a run time of 5 min, theoretical plate counts for ATN and CTN were 5366 and 6689 respectively, with a resolution of 7.79. As per ICH guidelines the method was validated for linearity, accuracy, precision, and robustness. The correlation coefficient for ATN and CTN were 0.999 and 1 respectively. This demonstrates that the developed method is simple, precise, rapid, selective, accurate and reproducible for dissolution studies of ATN and CTN in immediate release tablet dosage form by RP-HPLC.