REVERSE PHASE HIGH-PERFORMANCE LIQUID CHROMATOGRAPHY (RP-HPLC) METHOD DEVELOPMENT AND VALIDATION FOR SIMULTANEOUS ESTIMATION OF SILDENAFIL CITRATE AND DULOXETINE HYDROCHLORIDE IN COMBINE DOSAGE FORM

Abstract

Sildenafil citrate (SIL) and Duloxetine (DULO) is a combination, which is a serotoninnorepinephrine reuptake inhibitor (SNRI). The primary goal of the endeavor is to develop and evaluate a stability-indicating reverse-phase liquid chromatography (RP-HPLC) technique for determining Sildenafil citrate and Duloxetine hydrochloride in the combined dosage form. Estimation of Sildenafil citrate and Duloxetine hydrochloride in pharmaceutical dosage form was carried out using Thermoscientific C18BDS- (25 cm x 4.6
mm x 5 mm). The mobile phase used consisted of Acetonitrile: Phosphate buffer (50:50%v/v), and the pH of the mobile phase was adjusted to 4.0 using 0.5%v/v Orthophosphoric acid. The flow rate was 1.0mL/min. The UV detection was done at 290nm. The injection volume was 20μl. Forced degradation studies including hydrolytic (acidic, basic, and neutral), oxidative, and thermal, have been carried out according to ICH Q1A (R2) guidelines. Potential degradation was found in acidic, oxidative, and basic environments.
The development of the method was validated according to ICH guidelines, and the findings were deemed acceptable. The devised stability-indicating technique effectively evaluated sildenafil citrate and duloxetine in the pharmaceutical tablet dosage form in the presence of a degradation product, with test results showing satisfactory recovery.