Development and Validation of RP-HPLC method for simultaneous estimation of Methyldopa and Hydrochlorothiazide in Pharmaceutical Dosage Form
A new simple accurate and economical reverse phase high performance liquid chromatographic method was developed for the determination of Methyldopa and Hydrochlorothiazide in bulk and tablet dosage form. The separation was eluted on a Hypersil BDS C8 column (250 mm x 4.6 mm; 5μ) using a mobile phase mixture of mixed phosphate buffer 5.5 and acetonitrile in a ratio of 50:50 v/v at a flow rate of 1.0ml/min. The detection was made at 287 nm. The retention times were 2.17min for Methyldopa and 3.56min for Hydrochlorothiazide. Calibration curve was linear over the concentration range of 62.5-375.0 μg/ml for Methyldopa and 6.25 to 37.5 μg/ml for Hydrochlorothiazide. The propose method was validated as per the ICH guidelines parameters like Linearity, specificity, precision, accuracy, robustness and ruggedness. The method was accurate, precise, specific and rapid found to be suitable for the quantitative analysis of the drug and dosage form.
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