Development and Validation of Stability Indicating Method for Simultaneous Estimation of Paritaprevir, Ombitasvir, and Ritonavir in Tablet Dosage Form

Abstract

This study aimed to optimize and validate methods for the analysis of Paritaprevir, Ombitasvir, and Ritonavir. Paritaprevir, Ombitasvir, and Ritonavir were separated using the Reverse phase – High performance liquid chromatographic technique equipped photo diode array detector with Kromasil C18, 150 x 2.6mm, 5µ column using Buffer: ACN = 40: 60 percent V/V. Separation is achieved with isocratic elution mode. The flow rate optimized at 1mL/min, with detection at 240nm. With a 10µL injection volume, the temperature of the column is kept at 30°C. According to ICH guidelines, the approach was validated for system suitability, linearity, robustness, precision, and accuracy. The limit of detection (µg/mL) for Partaprevir, Ombitasvir, and Ritonavir is found to be 0.37, 0.06, and 0.24 respectively. The limit of quantification (µg/mL) for Partaprevir, Ombitasvir, and Ritonavir is found to 1.11, 0.18, and 0.71 respectively. The six minute analytical run time demonstrates the speed of analysis, allowing for a higher number of samples to be evaluated per unit time. Forced degradation studies using various conditions like acid, base, peroxide, thermal, U.V, and hydrolysis were carried out and in all cases and the peak purity passes. Thus the method is found as stability indicating as per ICH guidelines.