Abstract
STABILITY INDICATING ANALYTICAL METHOD DEVELOPMENT AND VALIDATION FOR SIMULTANEOUS ESTIMATION OF RESERPINE AND DIHYDRALAZINE IN PURE AND MARKETED DOSAGE FORM BY USING HPLC
Humera Naaz, Swaroopa Rani, *Dr. A. Yasodha
ABSTRACT
A rapid and precise Reverse Phase High Performance Liquid Chromatographic (RP-HPLC) method has been developed for the validation of Reserpine (RES) and Dihydralazine (DHZ) in its pure form as well as in tablet dosage form. Chromatography was carried out on an Altima C18 (4.6 X 150 mm; 5?m) column using a mixture of ACN, Methanol and Phosphate buffer pH 4.6 (10:25:65 v/v) as the mobile phase at a flow rate of 1.0 ml/min, the detection was carried out at 215 nm. The retention time of Dihydralazine and Reserpine was 2.344 and 3.286 ±0.02 min respectively. The method produced linear responses in the concentration range of 10-50 mg/ml of Dihydralazine and 2.5-12.5 mg/ml of reserpine. The method precision for the determination of assay was below 2.0 % RSD. The method is useful in the quality control of bulk and pharmaceutical formulations.
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