RP-HPLC Method for the Simultaneous Determination of Pantoprazole Sodium, Omeprazole, Rabeprazole Sodium, Lansoprazole, and Domperidone in Bulk and Pharmaceutical Dosage Form

摘要

An RP-HPLC method for the simultaneous determination of Pantoprazole sodium, Omeprazole, Rabeprazole sodium, Lansoprazole, and Domperidone in tablets was developed and validated as per ICH and FDA guidelines. The separation was achieved with a 150 mm x 3.0 mm, 3.5 μm C18 column, by using a simple linear gradient. Mobile phase A was Buffer (1.0% Triethylamine containing 20mM KH2PO4; pH adjusted to 7.5 with Orthophosphoric acid) and Mobile Phase B was a mixture of Buffer and Solvent mixture in the ratio 20:80 v/v (Solvent mixture is mixture of Acetonitrile and Methanol in the ratio of 20:80 v/v) and with simple gradient program was delivered at a flow rate of 0.5 mL/min. The column temperature was kept at 30°C. The detector was set at the wavelength of 285 nm. Injection volume was kept 10 μL. The gradient separation was achieved within 25 minutes. The linearity of the proposed method was investigated in the range 0.018-0.057 mg/mL (r2= 1.000) for Pantoprazole sodium, 0.009-0.031 mg/mL (r2= 1.000) for Omeprazole, 0.009-0.027 mg/mL (r2= 1.000) for Rabeprazole sodium, 0.014-0.045 mg/mL (r2= 1.000) for Lansoprazole and 0.014-0.044 mg/mL (r2= 1.000) for Domperidone. The assay method is considered to be specific as there was no blank and placebo interference at retention time of Pantoprazole sodium, Omeprazole, Rabeprazole sodium, Lansoprazole, and Domperidone peaks. The developed method has an advantage that all the drugs can be quantified alone or in combination using a single mobile phase.