Research Journal of Pharmaceutical, Biological and Chemical Sciences Development and Validation of RP-HPLC Method for Content Analysis and Dissolution Studies Of Sitagliptin Phosphate Monohydratein Pharmaceutical Dosage Forms

Abstract

ABSTRACT A simple and accurate reverse phase high performance liquid chromatography (RP-HPLC) method for the validative determination of assay and dissolution of Sitagliptin Phosphate Monohydrate 100mg was developed and validated as per USP 1225 and ICH guidelines Q2(R1).The suitable chromatographic conditions were optimizedat a flow rate of 1.0ml/min along with the detection wavelength of 257nm.The method shows the linearity in the range of 50-150mg/mL with correlation coefficient of 0.9993.The assay value was obtained between 98%-101%. Precision shows relative standard deviation not more than 2%.The satisfactory conditions for the validation of dissolution were 900mL of distilled water at 37°C±0.5°C, basket apparatus with 100rpm stirring speed. The cumulative percentage drug release was found to be higher than 95% within 45min under the validated conditions. The stability of drug was satisfied up to 24hr at room temperature and at refrigeration and does not show any variations in the percentage drug release. The method was simple and free of sophisticate expenditure as it involves the usage of most commonly available reagents, medium and buffer. Hence, it was concluded that the proposed method was cost effective and sensitive for regular dissolution and content analysis determination of Sitagliptin Phosphate Monohydrate