Abstract

VALIDATION OF STABILITY INDICATING LC-MS ASSAY METHOD FOR DETERMINATION OF PANTOPRAZOLE SODIUM SESQUIHYDRATE.

D. Santhoshi Priya*, K. Prashanthi, B. Parijatha, Krishna Mohan Chinnala

ABSTRACT

In the present study, stability indicating assay of Pantoprazole sodium sesquihydrate was carried out according to ICH guideline Q1A(R2). The drug was subjected to acid (0.05NHCl), neutral and alkaline (0.5N NaOH) hydrolytic conditions at 70 °C, as well as to oxidative decomposition at room temperature. Photolysis was carried out by dissolving in Acetonitrile: Water (1:1) and in solid state by exposing to UV light. The products formed under different stress conditions were investigated by LC and LC–MS. The LC method that could separate all degradation products formed under various stress conditions involved a Thermo scientific Hypersil Gold Column, C18 (50 X 2.1 mm, 5μ) and a mobile phase comprising of Acetonitrile and 10mM Ammonium Acetate buffer. The flow rate and detection wavelength were 1 mL min−1 and 286 nm, respectively. The developed method was found to be precise and accurate. Validation method was carried out as per ICH guidelines. The correlation coefficient for linear curve obtained between concentrations Vs. Area for standard preparations of Pantoprazole was 0.999.The drug showed instability in solution state under acidic, oxidative and photolytic stress conditions. Primarily maximum degradation products were formed in acidic conditions, though the same were also produced variably under other stress conditions.

Keywords: Gastric and duodenal ulcers, Proton pump inhibitors, Pantoprazole sodium sesquihydrate, Forced Degradation study, LC–MS.