Development and Validation of Method for Simultaneous Estimation of Sofosbuvir and Ledipasvir in Combined Pharmaceutical Dosage Form

Abstract

Validation is a process of establishing documented evidence, which provides a high degree of assurance that a specific activity will consistently produce a desired result or product meeting its predetermined specifications and quality characteristics. HPLC originally referred to the fact that high pressure was needed to generate the flow required for liquid chromatography in packed columns. In the beginning, instrument components only had the capability of generating pressures of 500psi (35 bar). Sofosbuvir (tradename Sovaldi) is a direct acting antiviral medication used as part of combination therapy to treat chronic Hepatitis C, an infectious liver disease caused by infection with Hepatitis C Virus (HCV) pka value 9.3, Ledipasvir is a direct acting antiviral (DAA) medication used as part of combination therapy to treat chronic Hepatitis C, an infectious liver disease caused by infection with Hepatitis C Virus having pka1 = 4.0, pka2 = 5.0. LediHep brand name of combined dosage form as tablet having strength is 90 mg Ledipasvir and 400 mg Sofosbuvir was used for study. Separately weighed 20 tablets and average weight of individual tablets were found out and weight equivalent to LED (90 mg) and SOF (400 mg) was taken into 100 mL volumetric flask and dissolved into 60 mL of HPLC grade Methanol with sonication for 20 minutes. The responses of standard solution measured with UV detector showed a good result at 247 nm for the RP-HPLC method. A validated stability-indicating RP-HPLC analytical method has been successfully applied for quantitative determination of LED and SOF in tablet dosage form. The stability-indicating RP-HPLC method developed meets the system suitability criteria and resolution of the parent drugs from its degraded products.

Keywords: HPLC, Ledipasvir, Sofosbuvir and Validation.