Stability indicating RP-HPLC method development and validation for the simultaneous estimation of pibrentasvir and glecaprevir in bulk and pharmaceutical dosage form

Abstract

A plain sailing, unambiguous, speedy and error-free methodology was progressed for the quantifiable concurrent estimation of Pibrentasvir and Glecaprevir in conglomerated pharmaceutical dosage form. The contrivance was based on Chromatographic separation of both the drugs in reverse phase mode using C18 (250 X 4.6 mm), 5μ by utilizing phosphate buffer (pH 4.0) and Methyl alcohol in the ratio of 30:70 v/v was allowed to flow through column at a rate of 1.0 ml/min, and the detection wavelength was set at 251 nm. The time of retention was found to be 2.205 min for Glecaprevir and 4.996 min for Pibrentasvir. The dimensionality of Glecaprevir and Pibrentasvir was in linear range with a parametric statistic of 0.999 and 0.999. The acceptance criteria of precision was RSD should be not more than 2.0%, and the method showed precision 0.6 and 0.5 for Glecaprevir and Pibrentasvir, which shows that the method was precise. % Assay was found as 100.83 and 100.23, which show that the method was useful for routine analysis. The total recovery was founded to be100.40% and 100.25% for Glecaprevir and Pibrentasvir. LOD and LOQ for Glecaprevirwas found as 2.98 and 10.00 and LOD and LOQ for Pibrentasvir was found as 3.00 and 9.98. The methodology was assessed by various validation parameters in accordance with ICH Guidelines which indicates the method can be employed for routine quality control analysis.