Stability Indicating HPLC and HPTLC Method for Estimation of Letermovir

Abstract

Aim: The aim of this study is to develop and validate High-Performance Thin-Layer Chromatography (HPTLC) and High-Performance Liquid Chromatography (HPLC) techniques for the quantification of Letermovir and its degradation products under various stress conditions. Materials and Methods: A CAMAG system was employed using silica gel 60 F254 plates for HPTLC. The mobile phase consisted of chloroform and methanol in a 9:1 (v/v) ratio, with detection performed at 257 nm. A Jasco Liquid Chromatographic System featuring a PU 2080 Plus pump and an MD 2010 Plus PDA detector was utilized in HPLC. The mobile phase was a mixture of methanol and water in a 90:10 (v/v) ratio, with a flow rate set at 1 mL/min. Both methodologies underwent validation for parameters including linearity, accuracy, precision, robustness, and detection/quantification limits. Forced degradation studies were carried out under acidic, alkaline, oxidative, neutral, photolytic, and thermal conditions. Results: The results demonstrated good linearity, with correlation coefficients of 0.9934 for HPTLC and 0.997 for HPLC. Forced degradation studies revealed that Letermovir is vulnerable to hydrolysis under acidic and basic conditions and oxidative environments. The methods proved to be sensitive, selective, accurate, and reproducible for the analysis of Letermovir and its degradation products. Conclusion: The HPTLC and HPLC methods developed in this study represent a significant advancement over previously established techniques for evaluating the stability and purity of Letermovir. They are dependable, sensitive, and appropriate for routine analysis in stability assessments of Letermovir within pharmaceutical formulations.