ANALYTICAL METHOD DEVELOPMENT AND VALIDATION FOR THE DETERMINATION OF OMEPRAZOLE IN CAPSULE DOSAGE FORM USING RP-HPLC METHOD

A method for the determination of Omeprazole in capsule dosage form by reverse phase high performance liquid chromatography has been developed. This is a simple, rapid, precise and an accurate method. The method was developed on a Inertsil C85μ, (4.6×250 mm) column using acetonitrile and buffer in the ratio of 27:73 where the buffer was 14% w/v disodium hydrogen orthophosphate as a mobile phase which was pumped at a flow rate of 1.0 ml/min and detection was done at 305 nm. The retention time of the drug was found to be 21 min. The method was validated for accuracy, precision, linearity, specificity, robustness. The linearity was observed in the range of 9.6 – 15.6 µg/ml. More than 97% recovery demonstrated the accuracy of the protocol. Intra-day and inter-day precision studies of the new method were less than the maximum allowable limit (RSD% ≤ 2.0 according to FDA). The method showed linear response with correlation coefficient (r2) value of 0.998 The results of recovery studies indicated that the method was accurate. Hence the developed method was found to be suitable for the estimation of Omeprazole in bulk and capsule dosage forms.