STABILITY INDICATING RP-HPLC METHOD FOR THE SIMULTANEOUS ESTIMATION OF PANTOPRAZOLE AND LEVOSULPIRIDE IN PHARMACEUTICAL DOSAGE FORMAbstract
Simple, sensitive, and rapid stability indicating RP-HPLC method for simultaneous estimation of Pantoprazole and Levosulpiride in pharmaceutical dosage form was developed and validated. The analysis was carried out on Hibar C18 column (250 × 4.6 mm, id, 5µ) and the mobile phase composition was 10 mM ammonium acetate (pH 4.0 adjusted using acetic acid): Acetonitrile in the ratio of 20:80% v/v with a flow rate of 1.0 mL/min at room temperature. The sample injection volume was 20 µL, and eluents of the isocratic elution mode were monitored at 241 nm. The retention time was 3.1 min and 5.2 min for Pantoprazole and Levosulpiride, respectively. The method was linear in the concentration range of 1-7 μg/ml for Pantoprazole sodium with an r2 of 0.9973 and 4-10 µg/ml of Levosulpiride with an r2 of 0. 9961. The LOD and LOQ were found to be 0.05 and 1.5 µg/ml for Pantoprazole and Levosulpiride. The drug stability was assessed under various stress degradation conditions at room temperature for 24 h. In photodegradation, the percentage of degradation of Levosulpiride and Pantoprazole when exposed to sunlight for 8 h was found to be 42.7% and 2.75%, respectively. Whereas under other stress conditions viz acidic, basic, and oxidative degradation studies carried out for 24 h, the % degradation of the active constituent was found to be 23.21%, 21.98%, and 22.98% for Levosulpiride & 100%, 100% and 66.78% for Pantoprazole respectively. The proposed method was validated as per ICH guidelines Q2B.
N. H. Shivaraju, G. Kowmudi, K. Anoop and K. Nagappan *
Department of Pharmaceutical Analysis, JSS College of Pharmacy, [A Constituent College – JSS Academy of Higher Education & Research] Udhagamandalam, Tamil Nadu, India.
19 February 2019
24 October 2019
26 October 2019
01 November 2019