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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

Pending Publication Date: 2021-02-19
乐泰药业有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, this patent application only detects the impurity lincomycin, clindamycin B and 7-epimine clindamycin and the content of clindamycin hydrochloride for injection, but cannot realize the detection of other impurities

Method used

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  • Impurity and quality detection method of clindamycin hydrochloride capsules
  • Impurity and quality detection method of clindamycin hydrochloride capsules
  • Impurity and quality detection method of clindamycin hydrochloride capsules

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[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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PUM

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Abstract

The invention discloses an impurity and quality detection method of clindamycin hydrochloride capsules. According to the method, related substances, dissolution rate and content in the clindamycin hydrochloride capsule are measured, and impurities such as lincomycin, 7-epilincomycin, clindamycin B, dehydroclindamycin, 7-epilincomycin, clindamycin isomers and the like can be detected. Methodological verification is carried out on related substances, including quantification limit, detection limit, accuracy and durability. Results show that the method is high in sensitivity and can meet analysisrequirements.

Description

Technical field[0001]The invention relates to a method for detecting impurities and quality of medicines, in particular to a method for detecting impurities and quality of clindamycin hydrochloride capsules. The invention belongs to the field of medical technology.Background technique[0002]Clindamycin was synthesized for the first time by Magerlein and others in 1966 by replacing the 7th hydroxyl group in the lincomycin molecule with chloride ions. In the 1970s, the finished product was marketed. The product has strong antibacterial activity and broad antibacterial spectrum. The positive bacteria have obvious antibacterial activity and can kill chlamydia, mycoplasma, Plasmodium falciparum and Toxoplasma gondii. It has achieved good results in the treatment of various infections including life-threatening severe infections. There are three preparations of clindamycin in clinical application: clindamycin hydrochloride, palmitate, and phosphate. The latter two preparations have no anti...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): G01N30/02G01N30/06G01N30/86
CPCG01N30/02G01N30/06G01N30/8634G01N2030/047
Inventor 郎伟君
Owner 乐泰药业有限公司
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