Impurity and quality detection method of clindamycin hydrochloride capsules
A technology of clindamycin hydrochloride and clindamycin, applied in the field of medicine, can solve the problems of inability to detect other impurities, and achieve the effect of high sensitivity and meeting analysis requirements
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[0064]1. Determination of related substances
[0065]a The chromatographic conditions are as follows:
[0066]Use octadecyl silane bonded silica gel as filler;
[0067]Mobile phase: Use 0.05mol / L potassium dihydrogen phosphate solution (each lml contains 6.8mg potassium dihydrogen phosphate, adjust the pH to 7.5 with 25% potassium hydroxide solution)-acetonitrile (volume ratio 55:45) phase;
[0068]Flow rate: 1.0mL per minute;
[0069]Detection wavelength: 210nm;
[0070]Column temperature: 30°C.
[0071]b Solution preparation:
[0072]Take the contents under the difference of the filling amount, mix them, accurately weigh an appropriate amount, add the mobile phase to dissolve and dilute to make a solution containing 4.0mg of contents per 1ml, filter, and take the additional filtrate as the test solution. Accurately measure an appropriate amount of clindamycin, and quantitatively dilute it with mobile phase to make a solution containing 80 μg clindamycin per 1 ml as a control solution.
[0073]c Known impuri...
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