SIMULTANEOUS ANALYSIS OF LEDIPASVIR AND SOFOSBUVIR IN BULK AND TABLET DOSAGE FORM BY STABILITY INDICATING HIGH PERFORMANCE LIQUID CHROMATOGRAPHIC METHOD

Battula Sreenivasa Rao; Mandapati Varaprasad Reddy; Bhatraju Sreenivasa Rao

Volume : VI, Issue : IV, April - 2017

SIMULTANEOUS ANALYSIS OF LEDIPASVIR AND SOFOSBUVIR IN BULK AND TABLET DOSAGE FORM BY STABILITY INDICATING HIGH PERFORMANCE LIQUID CHROMATOGRAPHIC METHOD

Battula Sreenivasa Rao, Mandapati Varaprasad Reddy, Bhatraju Sreenivasa Rao

Abstract :

A simple, sensitive, precise, selective and specific stability indicating reverse phase high performance liquid chromatography assay for sofosbuvir and ledipasvir has been developed. The chromatography was conducted using YMC C18 analytical column (5 μm; 4.6 mm × 250 mm). The mobile phase containing disodium hydrogen phosphate solution (0.1 M) pH 6.5 and acetonitrile (60:40 v/v); and the isocratic flow rate of 0.8 ml/min were used. Detection was made with photodiode array detector set at 282 nm. The retention time of sofosbuvir and ledipasvir was found to be 2.731 min and 5.850 min, respectively. Linearity was established for sofosbuvir and ledipasvir in the range of 80-240 μg/ml and 18-54 μg/ml, respectively. The good recovery (sofosbuvir – 100.92%-101.06%; ledipasvir – 99.52%-99.63%) and low relative standard deviation (sofosbuvir – 0.0788%; ledipasvir – 0.0085%) confirm the accuracy and precision of the proposed method, respectively. The applicability of the method was evaluated by the assay of sofosbuvir and ledipasvir in combined tablet dosage form. It is recommended that the proposed method can be used for the routine quality control analysis of sofosbuvir and ledipasvir in pure drug and its tablet dosage forms. Forced degradation study was also done and indicated that the proposed method can also be used for degradation evaluation of sofosbuvir and ledipasvir.