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Inspection method of isosorbide mononitrate sustained-release capsule related substances

A technology of isosorbide mononitrate and related substances, which is applied in the field of testing related substances of isosorbide mononitrate sustained-release capsules, can solve the problems of no detection method for isosorbide mononitrate sustained-release capsules, prolong the action time, etc., and achieve a systematic The effect of good applicability, good accuracy and good linear relationship

Inactive Publication Date: 2021-03-19
珠海润都制药股份有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0003] Isosorbide mononitrate sustained-release capsule is a sustained-release preparation, the elimination half-life is 4-5 hours, effectively prolongs the action time, is convenient for administration, and can effectively improve the quality of life of patients. There is no sustained-release information about isosorbide mononitrate in the prior art. For the detection method of capsules, our company has developed a detection method for related substances in isosorbide mononitrate sustained-release capsules for the first time

Method used

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  • Inspection method of isosorbide mononitrate sustained-release capsule related substances
  • Inspection method of isosorbide mononitrate sustained-release capsule related substances
  • Inspection method of isosorbide mononitrate sustained-release capsule related substances

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Experimental program
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Effect test

Embodiment 1

[0034] (1) Experimental materials and instrument conditions

[0035] Instrument: High performance liquid chromatography: Agilent 1260; Chromatographic column: BDS HYPERSIL C18, 250mm×4.6mm, 5μm; Flow rate: 1.0ml / min; Column temperature: 30±2℃; Injection volume: 20μl; Detection wavelength: 210nm , using methanol-water (30:70) as mobile phase A, methanol as mobile phase B, and eluted according to the following gradient:

[0036] .

[0037] (2) Experimental steps

[0038] (1) Prepare solutions, respectively prepare blank solution, blank excipient solution, system suitability solution, impurity reference solution, test solution and control solution;

[0039] Blank solution: mobile phase A.

[0040] Blank excipient solution: Weigh about 135mg of the blank excipient (approximately equivalent to 50mg of isosorbide mononitrate) in the prescribed amount, put it in a 50ml measuring bottle, add an appropriate amount of mobile phase A, dissolve it by ultrasonication, dilute to the ma...

Embodiment 2

[0086] Embodiment 2 Detection method system applicability test of the present invention

[0087] System suitability is achieved by measuring the repeatability of the reference solution. Requirement 5 RSD for the peak area of ​​isosorbide mononitrate in the reference solution is ≤5.0%. -5 pins, record chromatograms.

Embodiment 3

[0088] Embodiment 3 Detection method specificity of the present invention

[0089] (1) Specificity test

[0090] The specificity of the method is mainly to examine the peak identification and selectivity, and it is required that the blank solution and blank excipients should not interfere with the detection; in the system suitability solution, the separation between the isosorbide mononitrate peak and the isosorbide 2-mononitrate peak is >2.0 , the number of theoretical plates of the main peak ≥ 3000; the separation of each peak in the selective solution ≥ 1.5, the number of theoretical plates of the main peak ≥ 3000, the purity of the main peak ≥ 980; the separation of the main peak and adjacent impurity peaks in the test solution ≥ 1.5, the main peak Theoretical plate number ≥ 3000, main peak purity ≥ 980, after the system is stable, blank solution, blank excipient solution, 2-isosorbide mononitrate localization solution, isosorbide dinitrate localization solution, system su...

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Abstract

The invention belongs to the technical field of pharmaceutical analysis and relates to a method for detecting isosorbide mononitrate sustained-release capsule related substances, which is used for detecting isosorbide mononitrate sustained-release capsule related substances by using a convenient and quick high performance liquid chromatography and can be used for monitoring the quality of isosorbide mononitrate sustained-release capsules. The detection method provided by the invention can eliminate interference of peaks of auxiliary materials of the isosorbide mononitrate sustained-release capsule, is high in chromatographic peak separation degree of related substances, has relatively high system applicability, meets the standards in specificity, precision and accuracy, and is suitable forindustrial production. The method has characteristics of strong specificity, good system applicability, good precision, good accuracy, good linear relationship, good durability and the like, and meanwhile, the determination method disclosed by the invention is simple to operate, relatively short in used time, low in cost and short in consumed time.

Description

technical field [0001] The invention relates to a method for testing related substances of isosorbide mononitrate sustained-release capsules, belonging to the technical field of drug analysis. Background technique [0002] Isosorbide mononitrate, English name: isosorbide mononitrate, can be divided into 5-isosorbide mononitrate and 2-isosorbide mononitrate, currently the most used is 5-isosorbide mononitrate, included in the Pharmacopoeia It is also 5-isosorbide mononitrate, its chemical name is 1,4:3,6-dianhydro-D-sorbitol-5-mononitrate, its molecular formula is: C6H9NO6, and its chemical structure is as follows: , Isosorbide mononitrate is the active metabolite of isosorbide dinitrate. Oral administration is not affected by hepatic metabolic effects. It enters the systemic circulation as the original drug. It is long-acting, with a half-life of about 5 hours and high bioavailability. It is clinically used for angina pectoris The prevention and treatment of coronary heart...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): G01N30/88
CPCG01N30/88G01N2030/884
Inventor 谢岳庭汪丽红安国川王晓翠谢斌兰柳琴
Owner 珠海润都制药股份有限公司
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