Method for improving stability of indapamide tablets in acidic solution

A technology for indapamide tablets and acidic solutions, which is applied in the field of improving the stability of indapamide tablets in acidic solutions, can solve the problems of reduced cumulative dissolution rate and influence on experimental data collection, and achieve the effect of improving stability

Active Publication Date: 2017-06-30
GRAND PHARM (CHINA) CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0004] However, ordinary indapamide tablets will be degraded after being dissolved in a strong acidic medium, resulting in a decrease in the cumulative dissolution rate after being injected into the high-performance liquid chromatograph at a certain interval, which affects the collection of experimental data.

Method used

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  • Method for improving stability of indapamide tablets in acidic solution
  • Method for improving stability of indapamide tablets in acidic solution
  • Method for improving stability of indapamide tablets in acidic solution

Examples

Experimental program
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Effect test

preparation example Construction

[0033] (1) Preparation of acidic solution: Weigh a certain amount of salt and acid, add water and dilute to 1000ml, determine its pH, mix well, and get ready.

[0034] (2) Add appropriate amount of additives, such as vitamin C, to the medium.

[0035] (3) Get indapamide tablet (2.5mg), add in the above-mentioned prepared medium, the rotating speed is 50 revolutions per minute, after 5min, 10min, 15min, 30min, 45min, 60min, 90min of stripping, take the appropriate amount of solution respectively, Discard 5ml of the initial filtrate, and take the subsequent filtrate as the test solution. Take an appropriate amount of the test solution immediately, respectively, at an interval of 5h, at an interval of 10h, and after an interval of 15h, inject it into a high-performance liquid chromatograph, and record the spectrum.

[0036] (4) Measuring conditions: the stationary phase of high performance liquid chromatography is octadecylsilane bonded silica gel, the mobile phase is 0.1% phosp...

Embodiment 1

[0038] Investigation of the effect of vitamin C concentration on the dissolution of indapamide in an acidic solution of hydrochloric acid at pH 1.2

[0039] The hydrochloric acid solutions of pH 1.2 (wherein the mass content of sodium chloride is 0.2%) were prepared with vitamin C mass concentrations of 0.01%, 0.02%, 0.03%, 0.05%, and 0.1%, respectively. The prepared samples are respectively 1-1#, 1-2#, 1-3#, 1-4#, 1-5#. Other steps are the same.

[0040] The assay results of dissolved indapamide are shown in Table 1.

Embodiment 2

[0042] Investigate the effect of pH value of acidic solution on the dissolution of indapamide in acidic solution of hydrochloric acid

[0043] The preparation pH is respectively the hydrochloric acid solution of 1.0, 1.2, 1.5, 2.2, wherein containing the sodium chloride that mass content is 0.2%, the sample that prepares is respectively 2-1#, 2-2#, 2-3# and 2- 4#. It is 0.02% to prepare vitamin C mass content again, and pH is respectively the hydrochloric acid solution of 1.0,1.2,1.5,2.2, wherein contains the sodium chloride that mass content is 0.2%, the sample that prepares is respectively 2-5#, 2- 6#, 2-7#, 2-8#. Other steps are the same.

[0044] The assay results of dissolved indapamide are shown in Table 1.

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Abstract

The invention discloses an acidic solution capable of improving the stability of indapamide tablets. The acidic solution is characterized by being a hydrochloric acid solution. The acidic solution also can contain vitamin C. After the vitamin C is added into the acidic solution, the stability of indapamide tablets is improved unexpectedly and remarkably, adverse impact on the dissolution rate of the indapamide tablets in the acid solution, for example the dissolution rate of the indapamide tablets in the acidic solution is not remarkably increased, is avoided, and the subsequent measurement of the dissolution rate of the indapamide tablets in is benefited.

Description

technical field [0001] The invention relates to a method for improving the stability of indapamide tablets in acidic solution. Background technique [0002] Indapamide is a sulfonamide diuretic with a molecular weight of 365.83. It has diuretic and calcium antagonistic effects and is a potent and long-acting antihypertensive drug. It is also clinically used for the treatment of water and sodium retention in congestive heart failure. [0003] [0004] However, ordinary indapamide tablets will be degraded after being dissolved and sampled in a strong acidic medium, resulting in a decrease in the cumulative dissolution rate after injection into the high-performance liquid chromatograph after a certain interval of time, which affects the collection of experimental data. Contents of the invention [0005] For this reason, one of the present invention provides a kind of acidic solution that improves the stability of indapamide tablet, and described acidic solution is hydroch...

Claims

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Application Information

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IPC IPC(8): G01N30/06
CPCG01N30/06
Inventor 王洪萍朱婷王芝练城
Owner GRAND PHARM (CHINA) CO LTD
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