Abstract

Reversed Phase HPLC for a Validation and Determination of Udenafil (Zydena^®) and Dapoxetine (Priligy^®) Simultaneously in Tablet Dosage Form in Jordanian Market

Author(s): Wael Abu Dayyih, Zainab Zakarya, Alice Abu Dayyih, Israa Al-Ani

A reversed phase high performance liquid chromatography was developed for estimation and determination of two actives pharmaceutical ingredient Udenafil (Zydena) and Dapoxetine (Priligy). In presence of pregabalin as internal standard. The chromatographic conditions were applied according to ICH-guidelines using Thermo Hypersil BDS–C18 (250 mm × 4.6 mm, 5.0 μ) the mobile phase containing acetonitrile: 0.2% triethyl amine in pure water (H₂O) the adjusted pH was 4.4 using ortho- phosphoric acid (75: 25) with flow rate amount approximately 1 ml/min using UV detection at 246 nm. Limit of detection was established to be 0.015 μg/ml and Limit of Quantification (LOQ) was found to be 0.025 μg/ml for udenafil and the Limit of Detection (LOD) of dapoxetine HCl 0.020 μg/ml. according to ICH-guidelines and statistical treatment of date the date for this method was linear with correlation coefficient R² > 0.99 which prove that the method is convenient and applicable for the investigation and study of udenafil and dapoxetine HCl in drug formulation and commercials tablets found in Jordanian pharmaceutical market beyond any interference or interaction with the additives materials or the excipients.

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