DEVELOPMENT AND VALIDATION OF RP-HPLC METHOD FOR THE ESTIMATION OF TRANDOLAPRIL AND VERAPAMIL IN COMBINED TABLET DOSAGE FORM

摘要

A reverse phase high performance liquid chromatographic method was developed and validated as per ICH guidelines for estimation of trandolapril and verapamil in combined tablet dosage form. The separation was obtained using a mobile phase consisting of acetonitrile and phosphate buffer adjusting pH to 3.0 in the ratio of 70:30 V/V and using Waters C18 (250 x 4.6 mm, 5 mem) column maintained at ambient temperature. The flow rate was 1.2 mL min~(-1) and UV detection was monitored at 215 nm. The retention time (min) and linearity range (meg mL~(-1)) for trandolapril and verapamil were (5.12, 2.70) and (20-60, 20-60), respectively. The method validation results are within the acceptance criteria for precision, accuracy and linearity. The proposed method was found to be suitable for routine quality control of marketed formulation containing these APIs.