STABILITY INDICATI?G ASSAY METHOD DEVELOPMENT AND VALIDATION FOR ONDANSETRON HYDROCHLORIDE AND PANTOPRAZOLE SODIUM IN BULK AND PHARMACEUTICAL DOSAGE FORM

Patel Nitya*, Dr. Omray Lavakesh, Mr. Soni Pushpendra

Radharaman Institute of Pharmaceutical Sciences, Bhopal, Madhya Pradesh, India

ABSTRACT

RP-HPLC method showed adequate linearity from 100-600 μg/mL for PAN (Pantoprazole sodium) and 10- 60 μg/ml for OND (Ondansetron). The mean recoveries for all methods were found in between 98 %-102 % for both the drugs. The RP-HPLC method successfully separated Pantoprazole and Ondansetron from degradation products formed under stress conditions like acidic, alkali, oxidative, photolytic and thermal. PAN degraded significantly under acidic, neutral, oxidative, photolytic and thermal conditions and gave 1 degradation products respectively, whereas OND degraded significantly under oxidative conditions and gave 1 degradation product each condition. Both the drugs were found to be stable under alkali conditions. HPTLC method showed adequate linearity from 200-1200 μg/band for OND and 2000-12000 μg/band for PAN.

Keywords:

Pantoprazole, RP-HPLC, Ondansetron, Antiemetic.