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Validation of a HPTLC densitometry method for the quantitative determination of mirtazapine in tablet formulations

T.Sheshashena Reddy, P.Sita Devi

Asensitive, selective and preciseHPTLCmethod of analysis ofmirtazapine in formulations was developed and validated. The method employed TLC aluminiumplates precoated with silica gel 60 F254 as the stationary phase. The solvent system consisted of toluene-acetone-methanol solution (6:2:2v/v/v). This systemwas found to give compact spots for mirtazapine (Rf value of 0.50+0.02).Densitometric scanning ofmirtazapinewas carried out in the absorbance/reflection mode at 298 nm. The linear regression analysis data for the calibration plots showed good linear relationship with r=0.999, and respectively. The method was validated for precision, robustness, ruggedness and recovery. The limits of detection and quantification were 24.37ng per spot and 81.25ng per spot, respectively.