Abstract

METHOD DEVELOPMENT AND VALIDATION OF VARDENAFIL IN BULK DRUG FORM USING RP-HPLC

Chiranjeevi Rishitha, Kirti Kumari Sharma, Vegesna Swetha*, Vaidya Jayathirtha Rao

ABSTRACT

A flow method of RP-high-performance liquid chromatography (HPLC) separation and quantification of vardenafil in bulk form by using PDA (photo diode array) detector. The separation chromatographic column employed was purosper RP-18 (5μm, 250mm×4.6mm). The mobile phase used was methanol: water (80:20) with the wavelength of detection 300nm. Retention time of vardenafil was obtained at 3.945min with the flow rate 1ml/min. 5μl/ml sample volume was injected to perform method development and method validation parameters such as accuracy, precision (intraday and interday), system suitability, specificity, robustness and ruggedness. The limit of detection and limit of quantification (LOD and LOQ) was found to be 0.01 and 0.03 μg/ml. The developed method was found to be in accordance with the ICH guidelines. Therefore, the proposed RP-HPLC method can satisfactorily be employed for qualitative and quantitative determination of vardenafil.

Keywords: RP-HPLC, Vardenafil, Methanol.