Abstract

RP-HPLC METHOD DEVELOPMENT AND VALIDATION FOR SIMULTANEOUS ESTIMATION OF ESOMEPRAZOLE AND ONDANSETRON IN COMBINED TABLET DOSAGE FORM.

Poornima A.N*, Satishkumar Shetty A, Manzoor Ahmed, Vijaya Krishna C Aradhya, Ravi M.C, Anil Kumar S.M.

ABSTRACT

The objective of the current study was to develop a simple, accurate, precise and rapid RP-HPLC method and subsequently validate as per ICH guidelines for the determination of Esomeprazole (ESO) and Ondansetron (ONDA) using mobile phase [A mixture of Acetonitrile and Methanol in the ratio of 60:40 was considered to be the optimal composition] as the solvent. The proposed method involves the measurement of retention time at selected analytical wavelength 260.0 nm was selected as the analytical wavelength. The retention time of ESO and ONDA was found to be 3.395 and 4.254 respectively. The linearity of the proposed method was investigated in the range of 10-50 μg/ml (r = 0.9999) for ESO and 04-20 μg/ml (r = 0.9999) for ONDA respectively. The method was statistically validated for its linearity, accuracy and precision. Both inter-day and intra-day variation was found to be showing less % RSD (Relative Standard Deviation) value indicating high grade of precision of the method.

Keywords: RP-HPLC method, Esomeprazole, Ondansetron, Validation