K. Spandana*1, N. Venkatesh1, K. Suresh2, U. Sambamoorthy1
1SARC – (Scientific and Applied Research Center) Hyderabad, India
2Pratishta Institute of Pharmaceutical Sciences, Durajpally, Suryapet, Hyderabad, India
A B S T R A C T
A simple, accurate, rapid, precise and novel Reverse phase Ultra Pressure liquid chromatographic method has been developed and validated for simultaneous determination of Domperidone and Rabeprazole in pharmaceutical dosage form. The chromatographic separation was carried out on a Symmetry C18 (2.1 x 100mm, 1.7mm, Make: BEH) or equivalent column with a mixture of Buffer (pH: 6.0 adjusted with ortho-phosphoric acid): Acetonitrile (35:65, v/v) as mobile phase; at a flow rate of 0.4 ml/min. The retention times for DOM and RAB were observed to be 2.391 and 4.602 min respectively. Calibration plots were linear (r2 >0.999) over the concentration range of 48,54,60,66,72 μg/ml for DOM and 32,36,40,44,48 μg/ml for RAB. The method was validated for accuracy, precision, specificity, linearity, robustness, sensitivity, LOD and LOQ. The proposed method was successfully used for quantitative analysis of tablets. No interference from any component of pharmaceutical dosage form was observed. Validation studies revealed that method is specific, rapid, reliable, and reproducible. The high recovery and low relative standard deviation confirm the suitability of the method for routine determination of Domperidone and Rabeprazole in bulk and in its pharmaceutical formulations.
Keywords: Domperidone, Rabeprazole and UPLC