Stability indicating RP-HPLC method for simultaneous estimation of Betamethasone dipropionate and Calcipotriene in bulk and pharmaceutical dosage form

摘要

The aim of the present study was to develop a reverse phase high performance liquid chromatographic (RP-HPLC) method for the simultaneous estimation of Betamethasone Dipropionate (BDP) and Calcipotriene (CPT). By using phosphate buffer (pH 3.0) and mobile phase consists of methanol: phosphate buffer mixed in the ratio of 70:30 % v/ v and Inertsil C18 column (4.6 x 250mm, 5 □m). The retention times (R_t) were found to be 2.669 min. and 3.855 min. for BDP and CPT respectively. For standard preparation Rt were found to be 2,569 min. and 3.842 min. BDP and CPT respectively. Both drugs produced linear responses with con-elation coefficient (r2) of 0.999. The percentage relative standard deviation (% RSD) are less than 2% indicating accuracy and precision of the method. The percentage recover}' varies from 98-101%. The limit of detection (LOD) and limit of quantification (LOQ) of BDP and CPT was found to 2.9, 10.03 and 3.0, 10.1 respectively and the results obtained was within the limit. The developed method was validated according to International Conference on Harmonization (ICH) guidelines for various parameters specified in ICH, Q2 (R1) guidelines and statistical analysis were found to be in good accordance with the prescribed values.This method was successfully validated as per ICH guidelines and proved to be suitable for routine quality control use.