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Detection method of related substances in clindamycin phosphate gel

A technology of clindamycin phosphate and related substances, which is applied in the field of drug detection and inspection, can solve the problems of affecting quality and inability to effectively control the quality of clindamycin phosphate gel, and achieves improved quality, good durability, strong specific effect

Active Publication Date: 2017-07-14
NINGXIA DUOWEI PHARMA
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  • Abstract
  • Description
  • Claims
  • Application Information

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Problems solved by technology

[0003] At present, "Chinese Pharmacopoeia" only has the assay method of clindamycin phosphate gel for clindamycin phosphate gel, because clindamycin phosphate gel is composed of the main drug clindamycin phosphate and lecithin, Hydroxypropyl cellulose and other excipients, in which excipients, impurities, etc. affect the quality of clindamycin phosphate gel, therefore, this simple method of content determination cannot determine the quality of clindamycin phosphate gel. Effective control

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  • Detection method of related substances in clindamycin phosphate gel
  • Detection method of related substances in clindamycin phosphate gel
  • Detection method of related substances in clindamycin phosphate gel

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Embodiment Construction

[0025] The present invention is illustrated with examples below, and it should be understood that the examples are used to illustrate the present invention rather than limit the present invention. The scope and essential content of the present invention are defined by the claims.

[0026] The clindamycin phosphate gel in the following examples comes from Ningxia Duowei Pharmaceutical Co., Ltd.

[0027] 1. Detection method

[0028] 1. Preparation of the test solution: accurately measure an appropriate amount of clindamycin phosphate gel, put it in a 10ml measuring bottle, dissolve it with phosphate buffer-90% acetonitrile methanol solution (volume ratio 80:20) and dilute to the mark , to make a solution containing 2-4 mg of clindamycin phosphate gel per 1 ml, shake well, add 3-5 drops of saturated Reyzl's ammonium salt aqueous solution, shake, stand still, take the supernatant and filter , take the continued filtrate as the test solution; wherein the phosphate buffer is made ...

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Abstract

The invention provides a detection method of related substances in clindamycin phosphate gel. The detection method is established on the basis of screening of preparation conditions of a sample solution, purification in pretreatment of the gel and screening of chromatographic conditions. Methodology validation research proves that the method has high accuracy and specificity and is good in repeatability and durability. By controlling the related substances in the clindamycin phosphate gel, the quality of a product is improved.

Description

technical field [0001] The invention relates to the technical field of detection and testing of medicines, in particular to a detection method for related substances in clindamycin phospholipid gel. Background technique [0002] Clindamycin Phosphate Gel is mainly used in the treatment of acne vulgaris. Clindamycin was synthesized for the first time in 1966 by Magerlerin et al. who replaced the 7th hydroxyl group in the lincomycin molecule with chlorine. Clindamycin phosphate is a semi-synthetic derivative of clindamycin. It has no antibacterial activity in vitro, but it is fat-soluble, and it is easier to be absorbed through the skin than clindamycin. Antibacterial activity, the mechanism of action is to inhibit the early synthesis of bacterial proteins, thereby inhibiting Corynebacterium acnes and eliminating inflammation. [0003] At present, "Chinese Pharmacopoeia" only has the assay method of clindamycin phosphate gel for clindamycin phosphate gel, because clindamycin...

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): G01N30/02
CPCG01N30/02
Inventor 白洁陈德纲王春红王宏福王伟鹏
Owner NINGXIA DUOWEI PHARMA
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