Abstract

METHOD DEVELOPMENT AND VALIDATION OF METHENAMINE HIPPURATE AND ITS RELATED SUBSTANCES IN ACTIVE PHARMACEUTICAL INGREDIENTS BY HPLC

Kolli Venkata Durga*, Karavadi Thejomoorthy, Ch. Saibabu

ABSTRACT

A simple reverse phase HPLC method was developed and validated for the estimation of Methenamine Hippurate and its related Substances in Active Pharmaceutical Ingredient. The analysis was carried out on EMPOWER HPLC model equipped with X-Bridge C18 (250 mm× 4.6 mm, 5μm) column and UV-Detector. Buffer: Solvent mixture (95:5) v/v as Mobile Phase-A and Buffer: Solvent mixture (30:70) v/v as Mobile Phase-B (1.36g Potassium hydrogen phosphate and 1.74 g di potassium hydrogen phosphate into 1000 mL volumetric flask containing 1000 mL water, dissolve and adjust pH 7.0 with potassium hydroxide solution (1g in 10ml water) is Buffer) (Acetonitrile and methanol in the ratio of 70:30 %v/v is solvent mixture) at a flow rate of 0.6ml/min was employed for elution and the compounds were detected at 210nm at 350C. The method was validated as per the ICH guidelines. Linearity was observed in the concentration range of 50 to 150% with correlation coefficient 1.00. The percent of relative standard deviation of six replicate measurements was found to be 1.6 which indicates that the proposed method was precise. Therefore the developed method was simple, precise and accurate and can be successfully applied for the estimation of Methenamine Hippurate and its related substances in Active Pharmaceutical Ingredient.

Keywords: Methenamine Hippurate, Anti-bacterial, RP-HPLC, Validation, Impurity profile.