Abstract

DEVELOPMENT AND VALIDATION OF HPTLC METHOD FOR SIMULTANEOUS ESTIMATION OF AVANAFIL AND DAPOXETINE HCl IN TABLET DOSAGE FORM

Hardik H. Chaudhari*, Prof. Dr. Dhrubo Jyoti Sen and Prof. Dr. C. N. Patel

ABSTRACT

A simple, economic, selective, precise, accurate and sensitive HPTLC method for analysis of Avanafil and Dapoxetine HCl, as a bulk drug and in formulation, was developed and validated according to ICH guideline. The method employed HPTLC aluminium plates precoated with silica gel 60F-254 as the stationary phase while the solvent consisted of toluene: methanol (9:1 v/v). The system was found to give compact spot for drug (Rf value of Avanafil and Dapoxetine was 0.37 and 0.52 respectively). Densitometric analysis Avanafil and Dapoxetine were carried out in the absorbance mode at 290 nm. The linear regression analysis data for the calibration plots of Avanafil and Dapoxetine showed good linear relationship, r2 = 0.9975 and r2 =0.9921 respectively, with respect to peak area in the concentration range 500-300 ng per spot. The method was validated for precision and recovery. The limits of detection and quantitation for Avanafil were 0.71 and 2.18 respectively and for Dapoxetine were 0.67 and 2.03 respectively. The precision (intra-day, inter-day) of method were found within limits (RSD <2%). The method was validated according to ICH guidelines. Thus the proposed method was simple, precise, economic, rapid and accurate and can be successfully applied for simultaneous estimation of Avanafil and Dapoxetine HCl in tablet dosage form.

Keywords: Avanafil, Dapoxetine HCl, HPTLC, Validation.