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Abstract

METHOD DEVELOPMENT AND VALIDATION OF RP-HPLC METHOD FOR THE SIMULTANEOUS ESTIMATION OF OMEPRAZOLE AND DICYCLOMINE HYDROCHLORIDE IN COMBINED TABLET DOSAGE FORM

Ch.Nikhila, M. Prasadarao

The main objective of the work is to develop a new, simple and economical method for the simultaneous estimation of omeprazole and dicyclomine hcl by using RP-HPLC technique In this method mobile phase of composition Phosphate buffer 0.02M,pH 6.5 and acetonitrile in the ratio of 65:35 was pumped with a flow rated of 1ml/min through C18 250mm column which was maintained at 25°C temperature. The wavelength 223nm was optimized as the both drugs have optimum absorbance. Volume of injection was 10µl. The retention time of the omeprazole and dicyclomine hcl was 2.02min and 9.93min respectively with appreciable resolution of 9.15. Using the above method the run was performed and the system suitability parameters were calculated and were within the limits. So the method was set for validation, the method was found to be specific in the determination of drug without any interference. The method was observed to be precisied as the %RSD was 0.59 and 0.63 for omeprazole and dicyclomine hcl respectively. Recovery studies were performed and found to be 99.45% for omeprazole and 100.35% for dicyclomine hcl. Calibration curve was plote and correlation coefficient was 0.999. The method was also found to be robust. The method was valid as all the parameters were passed. This method was precise, accurate and accurate, this method can be used in the regular assay of the formulations.


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