Abstract
ANALYTICAL METHOD DEVELOPMENT AND VALIDATION FOR THE ESTIMATION OF UDENAFIL IN BULK AND PHARMACEUTICAL DOSAGE FORM BY RP-HPLC

B.Siddartha*, Dr. I. Sudheer Babu

ABSTRACT

A simple, sensitive and rapid reverse phase high performance liquid chromatographic method was developed for the estimation of udenafil in pure and pharmaceutical dosage forms. A Altima C18 column (150 x 4.6mm x 5μm) was used as a stationary phase with a mobile phase containing a mixture of buffer (accurately weighed and transferred 1.36gm of Potassium dihydrogen orthophosphate in a 1000ml of volumetric flask add about 900ml of milli-Q water added add 1ml of triethylamine and degass to sonicate and finally make up the volumewith water, then pH adjusted to 3.1 with dil. Ortho phosphoric acid solution) and acetonitrile in the ratio of 60:40v/v. The flow rate was 1.0ml/min, the effluent was monitored at 246nm and eluted at 2.811min. Calibration curve was plotted with a range from 25-150μg/ml for udenafil and the correlation was found to be 0.9999.The accuracy range was found between 99.48% and 101.54%. The %RSD values for both intraday and interday precision were less than 1%. The limit of detection (LOD) and limit of quantification (LOQ) were found to be 1.015μg/ml and 3.075μg/ml respectively. The assay was validated for the parameters like specificity, system suitability, precision, accuracy, robustness and ruggedness parameters. The proposed method can be useful for the routine determination of udenafil in pharmaceutical dosage form.

Keywords: Udenafil, Calibration curve, RP-HPLC, Validation.


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