Stability indicating RP-HPLC method for simultaneous determination of L-Methyl folate and Escitalopram in bulk and pharmaceutical formulation

Abstract

Stabiliy indicating Reverse phase -HPLC Method been described for the simultaneous estimation of L-Methyl folate and Escitalopram in combined tablet formulation form. Chromatographic separation was carried out by using reversed phase HPLC and the method was achieved on a ODS column with UV detection. The mobile phase was optimized with Acetonitrile : 0.01% H3PO4in water 35:65 (%V/V) Flow rate of 1.0ml/min and The wavelength was selected at 212nm. The drug was stressed by acidic, alkaline, oxidative, thermal and photolytic conditions and the degradation samples were analyzed by the proposed method. Degradation studies showed that all the two drugs were degraded under oxidative, acidic, alkaline and thermal conditions, Minor degradation observed under photolytic and hydrolysis condition. Analytical Method validation parameters such as specificity, linearity, accuracy, precision, Ruggedness and Robustness were determined and System suitability of all the parameters was passed. Hence this method was stability indicating method, It can be used for the routine and Stability analysis of L-Methyl folate and Escitalopram in pharmaceutical dosage forms.