Development and Validation of a Reversed-phase Hplc Method for Simultaneous Determination of Domperidone and Pantoprazole in Pharmaceutical Dosage Forms

A simple reversed-phase high-performance liquid chromatographic (RP-HPLC) method has been developed and validated for simultaneous determination of domperidone and pantoprazole in capsules. The compounds were separated on an ODS analytical column with a mixture of methanol, acetonitrile, and triethylamine solution (10 mM, pH 7.0 ± 0.05 adjusted with 85% phosphoric acid) in the ratio 20:33:47 (v/v) as mobile phase at a flow rate of 1.0 mL min. UV detection was performed at 285 nm. The method was validated for accuracy, precision, specificity, linearity, and sensitivity. The developed and validated method was successfully used for quantitative analysis of Pantop-D capsules. Total chromatographic analysis time per sample was approximately 10 min with pantoprazole, acetophenone (internal standard), and domperidone eluting with retention times of 4.34, 5.52, and 9.46 min, respectively. Validation studies revealed the method is specific, rapid, reliable, and reproducible. Calibration plots were linear over the concentration ranges 0.5–5 μg mL and 1–10 μg mL for domperidone and pantoprazole, respectively. The LODs were 15.3 and 3.0 ng mL and the LOQs were 51.0 and 10.1 ng mL for domperidone and pantoprazole, respectively. The high recovery and low relative standard deviation confirm the suitability of the method for determination of domperidone and pantoprazole in capsules.