A New Force Indicating RP-HPLC Method Development and Validation for the Simultaneous Estimation of Pibrentasvir and Glecaprevir in Bulk and its Tablet Dosage Form

摘要

Background: A simple reversed phase high performance liquid chromatographic method was developed for the simultaneous estimation of the Pibrentasvir and Glecaprevir in bulk and its solid dosage form. Materials and Methods: The method was developed on water’s C18 column capacitate 250X4.6 mm, 5 μm particle size, wavelength was fixed at 225nm with photo diode array detection. The mobile phase was consisted mixture of 0.5 mM Ortho phosphoric acid buffer: Acetonitrile in the ratio of 75:25 v/v, pH 4.3 was adjusted with hydrochloric acid and flow of mobile phase through the column was maintained 1mL/min. Results: The retention times of Pibrentasvir and Glecaprevir were found to be 3.04 and 4.45 min respectively. The method was statistically validated with concern of precision, linearity, range and robustness of method was found for Pibrentasvir and Glecaprevir. The above method was afforded excellent percentage recovery was found to be 99.87-100.22% and 99.68-100.17% for Pibrentasvir and Glecaprevir respectively. The Limit of detection and Limit of quantification were found 0.12 and 0.43μg/mL and 0.008 and 0.027μg/mL for Pibrentasvir and Glecaprevir. The forced degradation studies were performed. Conclusion: The method was developed and validated for the estimation of Pibrentasvir and Glecaprevir. The method was sensitive, precise, accurate, and robust, showed good linearity with different concentrations. The method is used for the routine analysis of Pibrentasvir and Glecaprevir in its bulk and pharmaceutical dosage form.