Stability Indicating Assay Method for Simultaneous Estimation of Tadalafil and Dapoxetine Hydrochloride by RP-HPLC in Bulk

Khatal, Parnika Hareshwar and D’Souza, Kevita and Syeda, Alisha and Muddukrishna, B. S. and Vasantharaju, S. G. (2021) Stability Indicating Assay Method for Simultaneous Estimation of Tadalafil and Dapoxetine Hydrochloride by RP-HPLC in Bulk. Latin American Journal of Pharmacy, 40 (1). pp. 49-56. ISSN 03262383

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Abstract

A new simple validated RP-HPLC stability indicating assay method was developed for simultaneous estimation of dapoxetine hydrochloride and tadalafil in bulk drug. C18 Phenomenex Hyper Clone™ BDS column (250 × 4.5 mm, 5 μm), was used along with mobile phase composition of acetonitrile: potassium phosphate buffer 10 mM (55:45 at pH 3.2 ± 0.1). Flow rate for study was 1 mL/min whereas response curve was measured with photodiode array detector at 298 nm. Tadalafil retention time wa 3.9 min and that of dapoxetine hydrochloride was 4.9 min. Linearity of both drugs were found between the range of 6-16 μg/mL. The stability indicating ability of the method was establish by analysing drug sample by acid and alkaline hydrolysis, photolytic, oxidative and thermal conditions. The developed method is expeditious, precise and simple and can be implemented for quality control studies.

Item Type: Article
Uncontrolled Keywords: Dapoxetine Hydrochloride;High Performance Liquid Chromatography (HPLC);Tadalafil;
Subjects: Pharmacy > MCOPS Manipal > Pharmaceutical Quality Assurance
Depositing User: KMC Library
Date Deposited: 22 Feb 2022 04:42
Last Modified: 22 Feb 2022 04:42
URI: http://eprints.manipal.edu/id/eprint/158322

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