Sunday , 19 May 2024

RP-HPLC Method Development and Validation for Estimation of Omeprazole, Pantoprazole Sodium and Ranitidine HCl in Pharmaceutical Dosage Form

G. Saibhavani*1, A. Dinakar Reddy2
1Department of Pharmaceutical Analysis, Sun Institute of Pharmaceutical Education and Research, Kakupalli, Nellore, Andhra Pradesh, India.

2Professor & Principal, Sun Institute of Pharmaceutical Education and Research, Kakupalli, Nellore, Andhra Pradesh, India.

A b s t r a c t
A new method was established for simultaneous estimation of Omeprazole Pantoprazole Sodium and Ranitidine Hcl RP-HPLC method. Omeprazole Pantoprazole Sodium was freely soluble in water and alcohol. Ranitidine Hcl was freely soluble in alcohol and sparingly soluble in water. Methanol and potassium dihydrogen ortho phosphate (pH 3) was chosen as the mobile phase. The run time of the HPLC procedure was 5 minutes. The method was validated for system suitability, linearity, precision, accuracy, specificity, ruggedness robustness, LOD and LOQ. The system suitability parameters were within limit, hence it was concluded that the system was suitable to perform the assay. The method shows linearity between the concentration range of 10-100 µg /ml. The % recovery of Omeprazole Pantoprazole Sodium and Ranitidine Hcl were found to be in the range of 99.25 % – 98.22 %. The method was robust and rugged as observed from insignificant variation in the results of analysis by changes in Flow rate and Mobile phase composition separately and analysis being performed by different analysts.        

Keywords: Omeprazole Pantoprazole Sodium and Ranitidine HCl, RP-HPLC, Methanol.

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