Method for determining content of clindamycin phosphate vaginal tablets

A clindamycin phosphate and assay method technology, applied in the direction of measuring devices, instruments, scientific instruments, etc., can solve the problems of unclear separation of the main peak, large decrease in the content of the main peak, long retention time of the main peak, etc.

Active Publication Date: 2021-04-20
HAINAN HAISHEN TONGZHOU PHARM CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

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Problems solved by technology

[0003] Patent CN103487518B, using octadecylsilane bonded silica gel as filler; potassium dihydrogen phosphate solution-methanol as mobile phase, using high performance liquid chromatography for detection, the key control detection conditions, but the separation of the main peak in the content determination is not obvious, The content of the main peak decreases greatly, and the retention time of the main peak is relatively long

Method used

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  • Method for determining content of clindamycin phosphate vaginal tablets
  • Method for determining content of clindamycin phosphate vaginal tablets
  • Method for determining content of clindamycin phosphate vaginal tablets

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0033] The assay of embodiment 1 clindamycin phosphate vaginal tablet

[0034] HPLC detection conditions are as follows:

[0035] Stationary phase: octylsilane bonded silica gel;

[0036] Mobile phase A: Potassium dihydrogen phosphate-acetonitrile-water-heptafluorobutyric acid-ferric chloride, the volume ratio is 10:3:11:2:1;

[0037] Mobile phase B: a mass fraction of 0.1% aqueous formic acid;

[0038] Flow rate: 1.3ml / min;

[0039] Column temperature: 50°C;

[0040] Detection wavelength: 200nm;

[0041] The elution conditions are:

[0042] (1) From 0 to 5.0 minutes, the volume ratio of mobile phase A to mobile phase B is 40:60;

[0043] (2) From 5.01 to 9 minutes, the volume ratio of mobile phase A to mobile phase B is 55:45;

[0044] (3) From 9.01 to 25 minutes, the volume ratio of mobile phase A to mobile phase B is 75:25;

[0045] S1, get 8 clindamycin phosphate vaginal tablets (32mg), dissolve in ethanol after grinding, filter,

[0046] S2, measure the supernata...

Embodiment 2

[0048] The content determination of embodiment 2 clindamycin phosphate vaginal tablets

[0049] HPLC detection conditions are as follows:

[0050] Stationary phase: octylsilane bonded silica gel;

[0051] Mobile phase A: Potassium dihydrogen phosphate-acetonitrile-water-pentafluoropropionic acid-ferric chloride, the volume ratio is 15:8:15:4:3;

[0052] Mobile phase B: a mass fraction of 1.3% aqueous formic acid;

[0053] Flow rate: 1.5ml / min;

[0054] Column temperature: 70°C;

[0055] Detection wavelength: 400nm;

[0056] The elution conditions are:

[0057] (1) From 0 to 5.0 minutes, the volume ratio of mobile phase A to mobile phase B is 45:55;

[0058] (2) From 5.01 to 9 minutes, the volume ratio of mobile phase A to mobile phase B is 60:40;

[0059] (3) From 9.01 to 25 minutes, the volume ratio of mobile phase A to mobile phase B is 80:20;

[0060] S1, get 13 clindamycin phosphate vaginal tablets (52mg), dissolve in ethanol after grinding, shake well, filter,

...

Embodiment 3

[0063] The assay of embodiment 3 clindamycin phosphate vaginal tablets

[0064] HPLC detection conditions are as follows:

[0065] Stationary phase: Octylsilane bonded silica gel

[0066] Mobile phase A: Potassium dihydrogen phosphate-acetonitrile-water-trifluoroacetic acid-ferric chloride, the volume ratio is 13:5:12:3:2;

[0067] Mobile phase B: a mass fraction of 1.0% aqueous formic acid;

[0068] Flow rate: 1.4ml / min;

[0069] Column temperature: 60°C;

[0070] Detection wavelength: 210nm.

[0071] The elution conditions are:

[0072] (1) From 0 to 5.0 minutes, the volume ratio of mobile phase A to mobile phase B is 42:58;

[0073] (2) From 5.01 to 9 minutes, the volume ratio of mobile phase A to mobile phase B is 57:43;

[0074] (3) From 9.01 to 25 minutes, the volume ratio of mobile phase A to mobile phase B is 78:22;

[0075] S1, get 10 clindamycin phosphate vaginal tablets (40mg), dissolve in ethanol after grinding, filter,

[0076] S2, measure the supernatant 0...

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Abstract

The invention provides a method for determining the content of clindamycin phosphate vaginal tablets. The method adopts high performance liquid chromatography for detection, selects mobile phase components, adopts scientific proportioning, adopts gradient elution and sets elution conditions, and can rapidly and accurately detect the content of clindamycin hydrochloride for injection so as to achieve the purpose of simply, conveniently, rapidly and accurately controlling the product quality.

Description

technical field [0001] The invention relates to the field of drug analysis, in particular to a method for determining the content of clindamycin phosphate vaginal tablets. Background technique [0002] Clindamycin phosphate is a semi-synthetic antibacterial drug widely used in serious infections caused by Gram-positive cocci and anaerobic bacteria. It is a semi-synthetic antibiotic and a derivative of lincomycin. Clindamycin phosphate is ineffective in vitro and can be rapidly converted into antibacterially effective clindamycin in vivo. The clindamycin phosphate vaginal tablet has a high cure rate and a short course of treatment for bacterial vaginosis, and has the characteristics of convenient production and use and quick onset of effect. [0003] Patent CN103487518B, using octadecylsilane bonded silica gel as filler; potassium dihydrogen phosphate solution-methanol as mobile phase, using high performance liquid chromatography for detection, the key control detection cond...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): G01N30/02G01N30/34
CPCG01N30/02G01N30/34
Inventor 韦家华刘玉
Owner HAINAN HAISHEN TONGZHOU PHARM CO LTD
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