Development of Stability Indicating, Validated Liquid Chromatographic Method for Estimation of Sarecycline in its Formulations

Abstract

A stability indicating HPLC method was developed and for the estimation of Sarecycline Hydrochloride in tablet dosage form using C18 column with a mobile phase composition of 0.1M Na2PO4 and Acetonitrile in the ratio of 50:50 v/v . The detection wave maxima and retention time were found to 242nm and 3.876min respectively. The method validation was carried out according to International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use (ICH) guidelines and the parameters namely; precision, accuracy, specificity, stability, robustness, linearity, limit of quantitation (LOQ) and limit of detection (LOD) are evaluated. The present developed RP-HPLC method shows the purity angle of peaks is less than their threshold angle, signifying that it to be suitable for stability studies. Hence, the developed method can be used for the successful estimation of Sarecycline in the pharmaceutical dosage formulations.