Development and Validation of Venlafaxine Hydrochloride in Bulk and in Capsule Formulation by HPTLC

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چکیده

A simple, sensitive and rapid high performance thin layer chromatographic (HPTLC) method has been developed and validated for quantitative estimation of Venlafaxine hydrochloride in bulk and in capsule formulation. The drug was chromatographed on silica gel 60F254TLC plate using methanol: ammonia (4.5:0.5v/v) as mobile phase. Densitometric scanning of was carried out at 224 nm and resolution was found with Rf value 0.65±0.02. The linear regression analysis for the calibration plots showed good linear relationship with r2=0.998 in concentration range 500-3000ng/ spot. The minimum detectable amount was found to be 7.7ng/spot, whereas the limit of quantitation was found to be 23.3ng/spot. The method was validated for precision, recovery, repeatability and robustness as per the ICH guidelines. Statistical analysis of the data showed that the method is precise, accurate, reliable, reproducible, and selective for the analysis of Venlafaxine hydrochloride. The proposed method also indicates no interference of excipients from capsule formulation.

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تاریخ انتشار 2017