DEVELOPMENT AND VALIDATION OF RP-HPLC METHOD FOR THE ESTIMATION OF RAMOSETRON HYDROCHLORIDE IN BULK AND TABLETS

摘要

A RP-HPLC method was developed and validated for the determination of ramosetron hydrochloride in pharmaceutical formulation as per ICH and FDA guidelines. The method was carried out on a Phenomenex RP-C_(18) column using a mixture of methanol and water (95:5) in an isocratic mode. The flow rate is 0.8 ml_/min and the detection was done at 302 nm. The linearity range was observed in the range of 1-6 mcg/mL The accuracy of the method was found to be 99.0 to 99.5% and %RSD was found to be less than 2% indicating high degree of accuracy and precision for the proposed HPLC method. Limit of detection and limit of quantification of the method were found to be 0.028 and 0.0851 mcg/mL respectively.