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Development and validation of HPLC method for identification and determination of related substances in dimenhydrinate tablets

In the development of the method for identification and determination of related substances in Dimenhydrinate tablets by High Performance Liquid Chromatography (HPLC) method, following parameters have been optimized: column type, gradient time and flow rate. Method has been validated throughout following parameters: selectivity, linearity, accuracy, precision, robustness, detection limit and quantification limit. System suitability test and range have been determinated. Method complies with all the requirements made and it is considered appropriate for further use.

development; validation; HPLC; related substance; dimenhydrinate; tablet

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