Suresha DN

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. Keywords: Diltiazem Hydrochloride, Area under curve Spectroscopy, 0.1M Sulphuric acid, accuracy.  

An accurate, simple, rapid, precise and economical RP- HPLC method has been developed for the rapid estimation of ImatinibMesylate in bulk and pharmaceutical formulation. The separation was achieved on Phenomenex C18 G column ( 250 x 4.6 mm i.d, 5 μm), using Methanol : 1-octanesulphonic acid (0.05M) at PH-8 with KOH  70:30 (v/v) as mobile phase, at a flow rate of 1.0 ml/min. Detection was carried out at 269 nm and drug eluted with a retention time of 5.548 min. Beer’s law was obeyed in the concentration range of 2-12μg/ml with correlation coefficient 0.999. The method had been validated according to ICH guide lines for specificity, linearity, accuracy, precision, robustness, ruggedness, LOD and LOQ. The method was found to be specific, accurate, and precise, robust, rugged and sensitive. The proposed method was convenient for quantitative routine analysis and quality control of ImatinibMesylate in bulk and pharmaceutical dosage form. Key words: Imatinib Mesylate , RP-HPLC, Validation, 1-Octanesulphonic acid.