ABSTRACT: The day-by-day new combinations drugs are being launched in market. Then the multiple therapeutic agents which acts at diverse sites are used in the management of various diseases and disorders are done. Thus, it is necessary to develop methods for analysis with the help of number of analytical methods which are available for the estimation of the drugs in combination. The analyst was estimating the rapid, selective, specific, simple, RP- HPLC method is developed and validated for simultaneous estimation of Sofosbuvir and Ledipasvir in pharmaceutical tablet dosage form. RP-HPLC method was performed on the Intersil-ODS HPLC System equipped with SP930 D HPLC pump and dual wavelength UV-VIS detector and C18 column (250mm × 4.6mm, 5μm), using the mobile phase (Methanol: Water 60:40 v/v) pH 3.0 with 0.05% acidic acid at a flow rate of 1.0ml/min, injection volume 20μl and UV detection at 254nm. This method is validated according to BP, USP and ICH requirements for new methods, which include accuracy, precision, robustness, ruggedness, lod, loq, linearity and range. Linear relationships were obtained in the ranges of 20-80μg/ml and 20-80μg/ml with correlation coefficients of 0.9991 and 0.9994 at Rt value of 3.94min and 2.86min for Sofosbuvir and Ledipasvir respectively. According to ICH guidelines the developed method was validated. The proposed method can be used for estimation of these drugs in combined pharmaceutical dosage forms.
Boinipally Akshitha1, Dr V Jagadeesh Babu2
Sofosbuvir and Ledipasvir, RP-HPLC, Development and Validation.
