Review on Various Analytical Methods for Estimation of Ledipasvir From Its Bulk and Pharmaceutical Formulation

Ledipasvir, a direct-acting antiviral agent, plays a pivotal role in the treatment of hepatitis C virus (HCV) infection, particularly when used in combination with sofosbuvir. Ensuring the accurate estimation of Ledipasvir in bulk and pharmaceutical formulations is essential for maintaining drug quality and therapeutic efficacy. A wide array of analytical methods has been developed for this purpose, ranging from simple spectrophotometric techniques to advanced hyphenated methods such as liquid chromatography-mass spectrometry (LC-MS). This review explores these methods, highlighting their principles, methodologies, and applications. UV-visible spectrophotometry offers a cost-effective and straightforward approach for routine analysis, while chromatographic techniques like high-performance liquid chromatography (HPLC) and ultra-performance liquid chromatography (UPLC) are preferred for their precision and specificity. Hyphenated techniques, including LC-MS and HPLC with photodiode array detection, provide unparalleled sensitivity and are crucial for stability studies and pharmacokinetic analyses. Additionally, alternative methods like Fourier-transform infrared spectroscopy and capillary electrophoresis are discussed for their unique applications. Validation of these methods, adhering to ICH guidelines, ensures their reliability and reproducibility. This review also addresses challenges in Ledipasvir estimation, such as interference from excipients and the need for eco-friendly analytical practices. The integration of green chemistry principles into analytical methods is identified as a promising area for future research. Overall, this review provides a comprehensive resource for researchers and professionals aiming to develop and refine analytical techniques for Ledipasvir estimation.