STABILITY INDICATING RP-HPLC METHOD DEVELOPMENT AND VALIDATION FOR ESTIMATION OF TIAGABINE HYDROCHLORIDE IN TABLET
Journal: Indo American Journal of Pharmaceutical Sciences (IAJPS) (Vol.05, No. 04)Publication Date: 2018-04-09
Authors : Sonal Vaishnav H. Dr Vinay C.Darji Jaymin G.Patel Bhumi patel;
Page : 2836-2861
Keywords : Tiagabine Hydrochloride; Stability indicating RP-HPLC Method; Validation.;
Abstract
A simple, rapid, economical, precise and accurate Stability indicating RP-HPLC method for estimation of Tiagabine Hydrochloride in their dosage form has been developed. A reverse phase high performance liquid chromatographic method was developed for the simultaneous estimation of Tiagabine Hydrochloride. in their dosage form has been developed. The separation was achieved by column C18 (250mm x 4.6 mm) Hypersil BDS and Buffer (pH 4.5): Methanol (85:15 % v/v) as mobile phase, at a flow rate of 1 ml/min. Detection was carried out at 260 nm. Retention times of Tiagabine Hydrochloride were found to be 4.210 min, respectively. The method has been validated for linearity, accuracy and precision. Linearity observed for Tiagabine Hydrochloride 5-15 μg/ml. Developed method was found to be accurate, precise and rapid for estimation of Tiagabine Hydrochloride In Their Dosage Form. The drug was subjected to stress condition of hydrolysis, oxidation, photolysis and Thermal degradation.The proposed method was successfully applied for the simultaneous estimation of both the drugs in commercial combined dosage form. Keywords: Tiagabine Hydrochloride, Stability indicating RP-HPLC Method, Validation.
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