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Clindamycin hydrochloride injection and preparation method thereof

Number of visits:1072 Date:2015/12/1 6:58:40
Determination of Clindamycin Hydrochloride Capsules and Related Substances by HPLC

Objective:An HPLC method has been established for the determination and related substances.Method:The chromatographic system consists of C18 column,mobile phase of a mixture of 6.8 g·L-1 potassium dihydrogen phosphate solution(adjusted to pH 7.5 with a 250 g·L-1 solution of potassium hydroxide)-acetonitrile R(55∶44) as the mobile phase.Detection wavelength is 210 nm.Results:The linearity was obtainted in the range of 0.24~2.4 g·L-1,the average recovery was 99.6%,RSD was 0.5%.6~8 related substances was detected.Conclusion:The method was simple and accurate,and had good robustness.

Clindamycin hydrochloride injection and preparation method thereof

The invention provides a clindamycin hydrochloride injection and a preparation method thereof. The clindamycin hydrochloride injection provided by the invention comprises 7.5wt% of clindamycin hydrochloride, 0.1-3wt% sodium pyrosulfite, 0.05-0.1vol% of acetic acid and 0.1-0.5wt% of sodium acetate, and the pH of the clindamycin hydrochloride injection is 4.0-5.0. The preparation method of the injection comprises the steps of: sterilizing by filtering twice with a 0.22mum degerming filter membrane and sub-packaging by filling nitrogen twice. The clindamycin hydrochloride injection provided by the invention has stable content, simple preparation process and low energy consumption during production, and is proved to be safe and have no obvious stimulation action through animal experiments.
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Sterility Test of Clindamycin Hydrochloride for Injection

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clindamycin hydrochloride capsules in healthy volunteers
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