Abstract
Objective: To develop an innovative, rapid, simple, cost effective, stability indicating reverse phase-high performance liquid chromatography (RP-HPLC) method for simultaneous estimation of ledipasvir (LP) and sofosbuvir (SB) in combination pill dosage form.
 Methods: The method was developed using C8 column, 250 mm x 4.6 mm, 5mm using mobile section comprising of 0.1% (v/v) orthophosphoric acid buffer at pH 2.2 and acetonitrile in the ratio of 45:55 that was pumped through the column at a flow rate of 0.8 ml/min. Temperature was maintained at 30 °C, the effluents were monitored at 260 nm with the help of usage of PDA detector.
 Results: The retention time of LP and SB were found to be 2.246 min and 3.502 min. The approach was found to be linear with the variety of 9-36 µg/ml and 40-240 μg/ml for LP and SB respectively, the assay of estimated compounds were found to be 99.65% and 99.73% w/v for LP and SB respectively.
 Conclusion: The pressured samples changed into analyzed and this proposed a technique turned into determined to be particular and stability indicating as no interfering peaks of decay compound and excipients were observed. Hence, the approach was easy and economical that may be efficiently applied for simultaneous estimation of both LP and SB in bulk and combination tablet system.
Highlights
Various drugs are used for the treatment of ailments, but sometimes multiple drug therapy is being followed for cure of chronic disease, as well as it has better patient acceptability due to reduced number of dosage forms to be taken at a time [1,2,3]
LP 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 (HCV)
After a number of trials with mobile phases of different composition, and a mobile phase containing 0.1% orthophosphoric acid buffer at pH 2.2 and acetonitrile taken in the ratio of 45:55 v/v was selected as a mobile phase because of better resolution more number of theoretical plates and symmetric peaks
Summary
Various drugs are used for the treatment of ailments, but sometimes multiple drug therapy is being followed for cure of chronic disease, as well as it has better patient acceptability due to reduced number of dosage forms to be taken at a time [1,2,3]. Several optimization techniques are employed using various latest experimental designs for the latest innovations in developmental methods [4]. In the present work we are trying to develop a method for combination of ledipasvir (LP) and sofosbuvir (SB) by RP-HPLC technique [5]. LP 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 (HCV). LP inhibits an important viral phosphoprotein, NS5A, which is involved in viral replication, assembly, and secretion
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