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Content detection method for glucosamine hydrochloride capsules

A technology of glucosamine hydrochloride and quality detection method, which is applied in the directions of measuring devices, instruments, scientific instruments, etc., can solve the problems of imperfect quality control method of glucosamine hydrochloride capsule, and achieves good recovery rate, good repeatability and good linear relationship. Effect

Inactive Publication Date: 2012-07-18
亚宝药业太原制药有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0003] At present, the quality control method of glucosamine hydrochloride capsules is not perfect

Method used

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  • Content detection method for glucosamine hydrochloride capsules
  • Content detection method for glucosamine hydrochloride capsules
  • Content detection method for glucosamine hydrochloride capsules

Examples

Experimental program
Comparison scheme
Effect test

experiment example 1

[0043] Experimental Example 1: System Suitability Experiment

[0044] Preparation of the test solution: Take an appropriate amount of the content (approximately equivalent to 100 mg of glucosamine hydrochloride), accurately weigh it, put it in a 100 ml measuring bottle, add water to dissolve, dilute to the mark, shake well, and obtain a solution with a concentration of about 1 mg / ml , The solution was filtered through a 0.45um microporous membrane, and the filtrate was taken as the test solution.

[0045] Preparation of reference substance solution: Take an appropriate amount of glucosamine hydrochloride reference substance, accurately weighed, and prepare solutions with a concentration of about 0.4 mg, 1 mg, and 2 mg in the same way as the test solution preparation method as the reference substance solution. The 2mg / ml reference substance solution was used as a stock solution.

[0046] Preparation of negative excipient solution: weigh about 100 mg of excipient according to t...

experiment example 2

[0049] Experimental example 2: Linear relationship experiment

[0050] Get the reference substance stock solution (2mg / ml), add water and dilute to 0.4mg / ml, 0.8mg / ml, 1.2mg / ml, 1.6mg / ml, 2mg / ml different concentrations of the reference substance solution respectively. Draw 10ul of each reference substance solution respectively and inject into the liquid chromatograph. Calculate the linear equation and regression coefficient of the logarithm value of the sample volume and the logarithm value of the peak area, the results are shown in Table 1, attached Figure 4 .

[0051] Table 1 Linear range

[0052]

[0053] Regression equation: y=1.3842x+9.6798, correlation coefficient R 2 = 0.9989.

[0054] The experimental results show that the logarithmic value of the peak area and the logarithmic value of the injected volume have a good linear relationship when the injected volume is in the range of 4 μg to 20 μg.

experiment example 3

[0055] Experimental Example 3: Precision Experiment

[0056] Precisely draw 10ul of the reference substance stock solution (2mg / ml) and inject it into the liquid chromatograph. The determination was repeated 5 times, and the content of glucosamine hydrochloride was calculated according to the linear equation fitted in Experimental Example 2, and the results are shown in Table 2.

[0057] Table 2 precision experiment results

[0058]

[0059] The experimental results show that the precision of the instrument is good.

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Abstract

The invention discloses a content detection method for glucosamine hydrochloride capsules. The method adopts a high performance liquid chromatograph and evaporative light-scattering detection method; a chromatographic column is a DIKMAC18 column of 5 micrometers with the specification of 200mm*4.6mm; a mobile phase consists of acetonitrile and water; the flow velocity of 0.1% of trifluoroacetic acid is 0.55-0.65ml / min; the temperature of the column is 30 DEG C; an Alltech ELSD 2000 detector is adopted; the temperature of a drift tube is 65-75 DEG C; and the pressure of an air pump is 0.24-0.28Mpa. A reference substance stock solution, a test solution and a negative auxiliary material solution are absorbed and then injected into a liquid chromatograph, a chromatogram map is recorded, a sample size log value is expressed as X, the corresponding peak area log value is expressed as Y, and linear fitting is conducted to obtain an equation of linear regression with the range of linearity between 0.8mg / ml to 1.2mg / ml.

Description

technical field [0001] The invention relates to a quality control method of medicines, in particular to a content determination method of glucosamine hydrochloride capsules. Background technique [0002] The content of glucosamine hydrochloride capsules in the original national drug standard WS1-(X-090)-2005Z was determined by ultraviolet-visible spectrophotometry. Sex is poor. The sample treatment of UV spectrophotometry requires derivatization reaction, the operation is relatively cumbersome, and the stability of the sample solution is not high, and the repeatability is not strong. [0003] At present, the quality control method of glucosamine hydrochloride capsules is not perfect. Contents of the invention [0004] The object of the present invention is to provide the content determination method of glucosamine hydrochloride capsule. [0005] The purpose of the invention is to realize through the following technical solutions [0006] The content determination metho...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): G01N30/88G01N30/06
Inventor 杨爱萍李艳艳康爱玲章文霞
Owner 亚宝药业太原制药有限公司
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