RP-HPLC method development and validation for the estimation of Diltiazem in bulk and tablet dosage forms

Abstract

The present research work deals with the development of RP-HPLC method for the determination of Diltiazem in bulk and in formulation using UV detector. A mixture of 0.01% of Trifluoroacetic acid in water and Acetonitrile in the ratio of 40:60 was used as mobile phase. The flow rate was kept at 1.6 ml/min, the injection volume was 25μl and the wavelength selected was 238 nm. The column used was Zorbax-SB Phenyl Column. The validation parameters used are System Suitability, Specificity, Precision, Accuracy, Linearity, Limit of detection (LOD), Limit of Quantification (LOQ), Solution Stability, Robustness and Ruggedness. All the validation parameters are carried as per ICH guidelines. The Retention time of Diltiazem was observed at 7.54 min. The proposed RP-HPLC method was found to be simple, sensitive and specific for the determination of Diltiazem in bulk and in tablet dosage forms.