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Abstract

DEVELOPMENT AND VALIDATION OF A ULTRA PERFORMANCE LIQUID CHROMATOGRAPHIC METHOD FOR ASSAY OF ALFUZOSIN HYDROCHLORIDE IN TABLET FORM

Masma Shaik*, Y. Sunandamma and Chinta Srinivasa Reddy

ABSTRACT

A simple, precise, accurate and specific chromatographic method is developed for for the determination of assay of alfuzosin hydrochloride in tablet form. An ultra-performance liquid chromatography instrument and Inertsil ODS-3, 3.0 x 50 mm, 2μ column were used for determination of alfuzosin hydrochloride. The flow rate of 1.0 mL/min was set with isocratic, the temperature of column compartment maintained at 25°C and Ultra violet detection done at 245nm wavelength. The injection volume was 5 μL. The alfuzosin hydrochloride peaks were eluted at 1.3 minute and total run time was set as about 2 minutes. . The developed method was validated in terms of system suitability, selectivity, linearity, precision, accuracy, and robustness for alfuzosin hydrochloride following the ICH guidelines.

Keywords: Alfuzosin hydrochloride, UPLC, Inertsil ODS-3 column, Method development, Method Validation.


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