Simultaneous Assay of Two Antiviral Agents, Pibrentasvir and Glecaprevir, Using Stability Indicating RP-HPLC Method in Bulk and Tablets

摘要

The aim of the current investigation was to develop and validate a rapid and simple stability indicating RP-HPLC method for simultaneous determination of two antiviral agents - pibrentasvir and glecaprevir in bulk drug and tablet dosage forms. The chromatographic separation and analysis was done using Sunsil C18 column (250 mm × 4.6 mm; 5 μm particle size) with mobile phase mixture of potassium dihydrogen phosphage (0.1 M; pH 4.0) and methanol in a ratio 55:45 (v/v). The chromatographic data was acquired using photodiode array detector monitored at 226 nm. The method was validated for linearity, sensitivity, selectivity, specificity, precision, accuracy and robustness. The method had shown good linearity over the concentration range of 5-80 μg/ml (R2 - 0.9997) for pibrentasvir and 12.5-200 μg/ml (R2 - 0.9998) for glecaprevir. All validation parameters data recorded were in acceptable limits. Degradation products, produced after subjecting pibrentasvir and glecaprevir to ICH prescribed stress conditions, did not interfere with the assay of selected drug combination. Therefore, the assay could be considered as stability-indicating. The method has been applied for assay of pibrentasvir and glecaprevir in their tablet forms with satisfactory accuracy and precision.