Development and Validation of New HPLC Method for the Quantitative Estimation of Naftopidil in Bulk and Pharmaceutical Formulation

A new, rapid, accurate, precise and economical method has been developed for the quantitative estimation of Naftopidil in bulk as well as pharmaceutical formulation. Isocratic elution with Inspire C18 (4.6 x 150mm, 5 mu m) column at ambient temperature was used. The mobile phase consist of a mixture of potassium dihydrogen orthophosphate buffer: acetonitrile (35%: 65% v/v) which was pumped at a flow rate of 1 ml/min. The eluent was detected by UV detector at 230 nm. The retention time was 2.585 min. The method was linear between the range of 2-10 mu g/ml with correlation coefficient of 0.9997. The proposed method was validated as per the ICH guidelines for all the parameters. The % RSD for the precision, method precision and ruggedness was calculated and was found to be 1.28, 1.076 and 0.17 respectively. Accuracy studies were carried out at three different levels i.e. 50%, 100% and 150%. The results obtained between the range of 98.23%-100.07% with a mean of 99.08%. LOD and LOQ for the proposed method was calculated and was found to be 0.01 mu g/ml and 0.03 mu g/ml respectively. Ruggedness studies were also carried out by altering the flow rate and organic composition of the solvent. No significant changes were seen with the altered conditions. The results obtained by the present investigation depicts that the developed method is precise, accurate, economical, rugged, and robust and can be utilized for the routine analyses of Naftopidil in bulk and pharmaceutical formulation.