A Novel Method Development and Validation of Deltiazem Hydrochloride in Pure and Pharmaceutical Dosage Forms by Using UV- Spectrophotometric Method

[摘要] A Novel, simple, accurate, and precise Area under curve spectroscopic method was developed and validated for the estimation of Diltiazem Hydrochloride in Pure and pharmaceutical dosage forms and has an absorption maximum between 232-242nm in 0.1M Sulphuric acid. The stock solution was made to produce 1000 µg/ml with 0.1M Sulphuric acid. The linearity was found in the concentration range of 1-3.5 µg/ml. The correlation coefficient was found to be 0.9999. The regression equation was found to be Y=0.1013x+0.002. The method was validated for linearity, accuracy, precision, limit of detection, limit of quantitation and ruggedness. The limit of detection and limit of quantitation for estimation of Diltiazem Hydrochloride was found to be 0.01066µg/ml and 0.1066µg/ml, respectively. Recovery of Diltiazem Hydrochloride was found to be in the range of 100.02-101.68 %. The %RSD values were less than 2. The method has been validated according to ICH guidelines. The Proposed method was successfully applied for the quantitative determination of Diltiazem Hydrochloride in pharmaceutical dosage forms.

[学科分类] 药学

[关键词] Diltiazem Hydrochloride;Area under curve Spectroscopy;0.1M Sulphuric acid;accuracy.