Validated RP – HPLC Method for Simultaneous Estimation of Tadalafil and Dapoxetine in Combined Pharmaceutical Dosage Forms
Abstract
ABSTRACT Aim: To develop a new, simple, fast, rapid, accurate, efficient and reproducible RP-HPLC method for the simultaneous estimation of Tadalafil and Dapoxetine. Background: Estimation of Tadalafil and Dapoxetine is a combination drug of choice used to treat preamature ejaculation in men. Objective: The main objective of the Simultaneous estimation of combined drug is to establish identity, physical characteristics and potency of the drugs and to demonstrate the suitability of the assay method to provide useful data to ensure the technique gives satisfactory and consistent results. Materials and methods: A HPLC (Inertsil, Water2695) with UV/VIS Detector/PDA detector, UV (lab India, UV 3000+ series) and Inertsil C18 250mm × 4.6mm × 5µm column was used. A new method was established for simultaneous estimation of Dapoxetine and Tadalafil by RP-HPLC method. The chromatographic conditions were successfully developed for the separation of Dapoxetine and Tadalafil by using inertsil C18 5µm (4.6*250mm) column, flow rate was 1ml/min, mobile phase ratio was Phosphate buffer (0.05M) pH 3: MEOH (30:70%v/v) (pH was adjusted with orthophosphoric acid), detection wave length was 260nm. Results: The results were in good agreement with those obtained with official HPLC with absorption maximum of 260 nm by preparing mobile phase 70:30 methanol: phosphate buffer with flow rate 1 ml/min and it run for 30 minutes by selecting column Inertsil C18 4.6mm×250 mm. All the results obtained with…
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