DEVELOPMENT AND VALIDATION OF A SENSITIVE AND SPECIFIC HIGH PERFORMANCE LIQUID CHROMATOGRAPHIC METHOD FOR ASSAY OF A BINARY MIXTURE OF PANTOPRAZOLE AND DOMPERIDONE IN ORAL SOLID DOSAGE FORMULATIONSAbstract
A simple new rapid, accurate, robust, and specific HPLC method was developed for the assay of pantoprazole and domperidone from the oral solid dosage pharmaceutical formulations. The reverse-phase chromatographic method was developed on an RP C8 column (250 mm × 4.6 mm, 5 µm) using a mixture of 25 mM sodium dihydrogen phosphate solution of pH 6.8 and methanol in the ratio 40:60 v/v as mobile phase in an isocratic mode of elution at a flow rate of 1.0 ml/min at 35 ºC with a load of 20 µl. The detection was carried out at 286 nm. The method was validated concerning linearity, robustness, precision, accuracy, specificity & stability as per ICH guidelines. The method produced excellent separation with good linear correlation coefficients (≥ 0.999) for both the components. The proposed method could be successfully applied for the assay of pantoprazole and domperidone in the various oral solid dosages pharmaceutical formulations, namely tablets and capsules in the sustained release form.
A. Basu and J. Chakraborty *
CSIR Central Glass and Ceramics Research Institute, Jadavpur, Kolkata, West Bengal, India.
04 February 2019
10 October 2019
20 October 2019
01 November 2019