UV-spectrophotometric method development and validation for estimation of Galantamine Hydrobromide in tablet dosage form

ABSTRACT:

Two innovative, new, simple and low cost UV-spectrophotometric and first order derivative methods were developed and validated for estimation of Galantamine Hydrobromide in bulk drug and tablet dosage form. Galantamine Hydrobromide was estimated at 289 nm in Distilled Water. In first order derivative, it showed amplitude at 284.8 nm and λminima = 290.4 nm with 286.4 nm as zero crossing point (ZCP). In both the methods linearity was found to be in the range of 20-100 µg/ml; for UV spectrophotometric method (y = 0.007x - 0.002, r² = 0.999) and for first order derivative spectrophotometric method (Y=0.0012 x+0.00045; r2=0.999), respectively. These methods were analyzed and validated for various validation parameters according to USP guidelines. The quantitation limits were found to be 0.50 and 1.54 µg/ml, for UV-Spectrophotometric method and 3.3 and 10 µg/ml for the 1st order derivative method. The proposed methods were successfully applied for the determination of Galantamine Hydrobromide in tablet dosage forms. The results demonstrated that the procedure is simple, accurate, cost effective, precise and reproducible (relative standard deviation <2%), while being simple, cheap and less time consuming and can be suitably applied for the estimation Galantamine Hydrobromide in different dosage forms.

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