Development and validation of rapid HPTLC method for determination of Darifenacin Hydrobromide in bulk drug and pharmaceutical dosage form

A simple, selective, precise, sensitive and accurate high performance thin layer chromatographic method of analysis for the determination of darifenacin hydrobromide in both bulk drug and in formulation was developed and validated. The method employed TLC aluminium plates precoated with silica gel 60 F 254 as the stationary phase. The solvent system consists of nhexane: ethyl acetate: triethylamine (7:2.5:0.5 v/v/v). This system was found to give compact spots for darifenacin hydrobromide (Rf value of 0.52 ± 0.02). Dentiometric analysis of darifenacin hydrobromide was carried out in the absorbance mode at 210 nm. The linear regression analysis data for the calibration plots showed good linear relationship with r = 0.9964 with respect to peak height and peak area, in the concentration range of 500-3000 ng per band. The method was validated for accuracy, precision and recovery.

Author(s): Sathish N.K 1  , Chethan I.A1, Pradeep.V.Khandelwal2 and Ashwinee Kumar Shrestha3

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