Consistency Evaluation of Two Clindamycin Palmitate Hydrochloride Preparations
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Consistency Evaluation of Two Clindamycin Palmitate Hydrochloride Preparations
Acta Scientiarum Naturalium Universitatis SunYatseniVol. 54, Issue 3, Pages: 115-118(2015)
作者机构:
1. 中山大学生命科学大学院,广东,广州,510275
2.
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Published:2015,
Published Online:25 June 2015,
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HUANG Xin, ZHANG Chao, LIN Feng, et al. Consistency Evaluation of Two Clindamycin Palmitate Hydrochloride Preparations. [J]. Acta Scientiarum Naturalium Universitatis SunYatseni 54(3):115-118(2015)
DOI:
HUANG Xin, ZHANG Chao, LIN Feng, et al. Consistency Evaluation of Two Clindamycin Palmitate Hydrochloride Preparations. [J]. Acta Scientiarum Naturalium Universitatis SunYatseni 54(3):115-118(2015)DOI:
Consistency Evaluation of Two Clindamycin Palmitate Hydrochloride Preparations
Consistency evaluation was processed between domestic clindamycin palmitate hydrochloride dispersible tables and the original oral solution. HPLC method was applied to detect related substances with acetate (A) and 5 mmol/L ammonium acetatesolutionacetonitrile (50:50) (B) as mobile phase eluting in gradient. Dissolution was conducted by stirring paddle method with w=0.4% SDS as dissolution medium
at the rotate speed of 75 r/min for quality comparison between two products.The results showed that the kinds and total contents of related substances in clindamycin palmitate hydrochloride dispersible tablets were lower than that of the original oral solution products and the dissolution rates of both products reached more than 94% in 20 minutes.