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Detection method of ACEI-containing composition and related substances

A technology of related substances and solutions, which is applied in the field of separation and detection of enalapril maleate and folic acid and related substances, can solve the problems of inability to detect simultaneously, large loss of chromatographic column, a large amount of foam, etc., and achieves injection precision. Good, system applicability, stable solution, low cost effect

Pending Publication Date: 2019-10-11
NANJING YOUKE BIOLOGICAL MEDICAL RES +3
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Using this method to detect enalapril maleate folic acid tablets, only maleic acid, folic acid, enalapril, enalaprilat and enalapril diketone, enalapril isomers, disc acid and p-aminobenzoyl glutamate could not be detected
Cetyltrimethylammonium bromide in the mobile phase is a cationic surfactant, which is soluble in water and produces a lot of foam when shaken. Long-term use will cause a large loss of the chromatographic column and easily cause damage to the equipment.
[0012] None of the above literatures can detect enalapril maleate folic acid and its related substances at the same time, so it is necessary to find a new detection method that can detect maleic acid, enalapril, and enalapril isotropic acid at the same time through one injection. Constructs, enalaprilat, enalapril diketone, folic acid, capric acid and p-aminobenzoyl glutamic acid

Method used

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  • Detection method of ACEI-containing composition and related substances
  • Detection method of ACEI-containing composition and related substances
  • Detection method of ACEI-containing composition and related substances

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0071] The determination of embodiment 1 detection wavelength

[0072] The absorption wavelengths of enalapril reference substance, folic acid reference substance and their related substances in the wavelength range of 200-400nm were respectively measured by ultraviolet spectrophotometer. All have maximum absorption at 215nm, and maleic acid, enalapril, enalapril isomers, enalaprilat, and enalapril diketone all have terminal absorption. Enalapril, enalapril isomers, enalaprilat and enalapril diketone had almost no absorption at 285nm, so 215nm was determined as the detection wavelength.

Embodiment 2

[0073] The screening of embodiment 2 chromatographic conditions

[0074] 2.1 Choice of diluent

[0075] Table 1 Dissolution of enalapril maleate and folic acid in different diluents

[0076]

[0077] As can be seen from Table 1, folic acid has poor solubility in sodium carbonate solution of phosphate buffer solution / acetonitrile=75:25 and 28.6g / L, and is completely dissolved in sodium carbonate solution of 0.01mol / L~0.1mol / L , so 0.01mol / L~0.1mol / L sodium carbonate solution can be used as diluent.

[0078] 2.2 Selection of detection conditions

[0079] Table 2 Screening of detection conditions for enalapril maleate folic acid and its related substances

[0080]

[0081]

[0082]

[0083] The sample tested by No. 1 is enalapril maleate reference substance, the samples tested by No. 2~3 are the mixed solution of enalapril maleate reference substance, folic acid reference substance and maleic acid reference substance, 9 The tested samples are enalapril maleate ref...

Embodiment 3

[0088] Embodiment 3 system applicability

[0089] Chromatographic conditions: Dionne U3000 high performance liquid chromatography system and workstation; automatic sampling; chromatographic column with octane-bonded silica gel as filler; UV detection wavelength: 215nm; mobile phase: phosphate buffer solution (0.02mol / L Potassium dihydrogen phosphate solution, adjust the pH to 2.5 with phosphoric acid) and acetonitrile, the gradient program is the same as in Table 3; the column temperature is 50°C, the injection volume is 20 μL, and the flow rate is 1.5 mL / min.

[0090] Preparation of diluent:

[0091] Take 0.02mol / L potassium dihydrogen phosphate solution, adjust the pH to 6.8 with saturated sodium hydroxide solution, add water to make up to 1L, and use it as a phosphate buffer solution.

[0092] Take 95mL of phosphate buffered saline and 5mL of acetonitrile, shake well, as a diluent.

[0093] Preparation of positioning solution:

[0094] Take the folic acid reference subst...

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Abstract

The invention provides an analysis and detection method for simultaneously measuring enalapril maleate folic acid and related substances, a high performance liquid chromatograph is adopted, octyl-bonded silica gel is used as a filler, a phosphate buffer solution with pH of 2-3 and acetonitrile are used as mobile phases, gradient elution is carried out, the detection wavelength is 210 nm to 220 nm,and the column temperature is 48-52 DEG C. According to the analysis and detection method provided by the invention, the effective separation of impurities is achieved by using gradient elution, theseparation degree of each absorption peak is greater than 1.5, the sample introduction precision is good, the system suitability solution is stable, and the method has good durability.

Description

technical field [0001] The invention belongs to the field of drug analysis, and in particular relates to a method for separating and measuring compositions containing angiotensin-converting enzyme inhibitors and related substances thereof by high performance liquid chromatography, in particular to enalapril maleate folic acid and its related substances Methods for the separation and detection of substances. Background technique [0002] The main risk factors of stroke are hypertension, hyperhomocysteine ​​(Hcy) hyperemia, abnormal blood sugar, abnormal blood lipids, etc. Among them, the intervention of hypertension and Hcy has the greatest impact on stroke. Epidemiological surveys on common cardiovascular and cerebrovascular risk factors show that the prevalence rates of hypertension, hyperglycemia, and high cholesterol in the Chinese population are significantly lower than those in the United States, but the Hcy level is 50% higher than that in the American population. The...

Claims

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Application Information

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IPC IPC(8): G01N30/02G01N30/34G01N30/06
CPCG01N30/02G01N30/34G01N30/06
Inventor 张峰姚洛芫朱素华薛峪泉刘春猛
Owner NANJING YOUKE BIOLOGICAL MEDICAL RES
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