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Abstract

A new, simple stability-indicating RP-HPLC and UV method for the simultaneous estimation of ledipasvir and sofosbuvir in bulk and  dosage form was developed. Chromatography was carried out using DonaZorbax C8, 250 × 4.6, 5 µm column with a flow rate of 1.0  mL/min. The mobile phase consisted of 0.1% orthophsophoric acid (OPA) and methanol in the ratio 45:55 and eluate was monitored at  238 nm. The retention times of ledipasvir and sofosbuvir were found to be 3.296 and 7.257 min, respectively. The method obeys Beer’s  law in the concentration range of 45-135 µg/mL for ledipasvir and 200-600 µg/mL for sofosbuvir. The LOD and LOQ were found to be  0.090 and 0.695, respectively for ledipasvir. The LOD and LOQ were found to be 0.6619 and 2.2063, respectively for sofosbuvir. The  accuracy of the method was assessed by recovery study in the dosage form at three concentration levels. The method developed has  been statistically validated according to ICH guidelines. The method showed good reproducibility and recovery with % RSD less than 2.  The stability indicating capability of the method was established by forced degradation studies under stress conditions like acid, base,  peroxide, UV, thermal, humidity. Hence, the chromatographic method developed for the estimation is found to be rapid, simple,  specific, sensitive, precise, accurate, robust and reliable that can be effectively applied for routine analysis. 

Keywords

Ledipasvir Sofosbuvir RP-HPLC UV spectroscopy

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Pendyala, V., Suryadevara, V., Kondeti, H. P., Vutla, V. R., & Nalla, S. (2024). A Stability Indicating RP-HPLC Method for Simultaneous Estimation of Ledipasvir and Sofosbuvir in Bulk and its Dosage Form. Asian Journal of Organic & Medicinal Chemistry, 8(3), 18–22. https://doi.org/10.14233/ajomc.2023.AJOMC-P28043
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