Spectrophotometric method for determination of dimethylamine in metformin hydrochloride via derivatization with 1-fluoro 2,4-dinitrobenzene

A rapid, simple and sensitive UV Spectrophotometric method has been developed for the quantitative estimation of dimethylamine in Metformin HCl drug substance and drug product .and validated as per ICH guidelines. The method was based upon the observation, that a characteristic colour results via dervatization with 1-Fluro2,4- dinitrobenzene. The addition of Flurodinitrobenzene reagent in dimethylamine dissolved in acetonitrile in the presence of triethyl amine results in the formation of yellow colour showing absorbance maxima at λ378nm. The developed method resulted as dimethylamine exhibiting linearity range 8 to 230 µg/g. The interday and intraday precision is exemplified by relative standard deviation of 0.149 % and 0.399%. .Percentage of mean recovery was found in the range of 98-101% during accuracy studies. The LOD and LOQ were found to be 15µg/g and 46µg/g respectively.

Author(s): K. Venkata Rao, Raja Gorla, B. Sreenivasulu, N. Sreenivas, T. Kaleemullah, Sharma Hemant Kumarand Raghu Babu Korupolu

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