Method Development And Validation For Azelnidipine In Bulk Drug And Tablet Dosage Form By Using UV- Spectrophotometer

Abstract

A simple, rapid, accurate and economical uv–spectrophotometric method developed for the estimation of Azelnidipine from bulk drug and pharmaceutical formulations. The lamda max of azelnidipine in isopropyl alcohol and ethyl alcohol (1:3) was found to be 256 nm. The drug follows linearity in the concentration range 10-320 µg/ml with a correlation coefficient value of 0.9979. the proposed method was applied to pharmaceutical formulation and % amount of drug was estimated as 98.0%-102.00% and was found to be in good agreement with the label claim. The accuracy of the method was checked by recovery experiment performed at three different levels, i.e 80%,100% and 120%. The % recovery was found to be in the range of 86.1%-89.03%w/w.The low values of % RSD are indicative of the accuracy and reproducibility of the method. The precision of the method was studied as an interday variations. the % RSD value <2 indicates that the method is precise.