Analytical method validation of few model drugs

Analytical procedure is the way of performing analysis and analytical method validation is an important job in quality control of Drugs. Analytically validated method ensures the quality of testing and produces reliable test results. The present work involves development of analytical methods to assay the active pharmaceutical ingredients of solid dosage forms by reverse phase HPLC techniques and their extensive validations following international guidelines. For the present study three solid dosage formulations were selected out of which two were tablet dosage forms containing two active pharmaceutical ingredients pantoprazole-domperidone and metformin hydrochloride-teneligliptin. The third solid dosage form was synthesized with pristine Mg-Al layered double hydroxide (LDH) nano particles intercalated with anticancer methotrexate drug. A reverse phase chromatographic method was developed for assay of pantoprazole and domperidone from oral solid dosage forms on a RP C8 column (250mm x 4.6 mm, 5μm) 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 C with a load of 20μl. The detection was carried out at 286 nm. Retention time of pantoprazole was found to be 3.4 min and that for domperidone was found to be 8.2 min. The method is simple, accurate, precise and robust. Another chromatographic method was developed for the simultaneous assay of metformin hydrochloride and teneligliptin hydrobromide from the tablet dosage formulations. The method was developed on a RP C18 column (250mm x 4.6 mm, 5μm) with a mixture of 20 mM ammonium acetate buffer of pH 5.5 and methanol in the ratio 50:50 v/v as mobile phase in an isocratic mode of elution at a flow rate of 1.0 ml/min. The detection wavelength was set at 255 nm. The column was maintained at a temperature of 35 C and a 20μl solution was injected. The retention time for metformin was found at 2.52 min and for teneligliptin it xvi was at 7.9 min. The method is found to be accurate, precise rugged, specific and stability indicating.