Separate detection method of ACEI-contained composition and relevant substances

A technology of related substances and detection wavelengths, which is applied in the field of separation and detection of enalapril maleate and folic acid and related substances, can solve problems such as inability to be detected at the same time, achieve good injection precision, improve work efficiency, and be durable good sex effect

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

AI Technical Summary

Problems solved by technology

[0012] None of the above literatures can detect enalapril maleate folic acid and its related substances at the same time. Therefore, it is necessary to find a new detection method that can detect maleic acid, enalapril, and enalaprilat at the same time through one injection. , enalapril, diketone, folic acid, capric acid and para-aminobenzoyl glutamic acid

Method used

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  • Separate detection method of ACEI-contained composition and relevant substances
  • Separate detection method of ACEI-contained composition and relevant substances
  • Separate detection method of ACEI-contained composition and relevant substances

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0072] Example 1 Determination of detection wavelength

[0073] The absorption wavelengths of enalapril, folic acid reference substance and related substances in the wavelength range of 200-400nm were measured with an ultraviolet spectrophotometer, and it was found that folic acid, benzyl glutamic acid and p-aminobenzoyl glutamate were both at 285nm and 215nm at the end There is maximum absorption. Maleic acid, enalapril, enalaprilat, and enalapril dione have terminal absorption. Enalapril has almost no absorption at 285nm, so 215nm is determined to be the detection wavelength.

Embodiment 2

[0074] Example 2 Screening of chromatographic conditions

[0075] 2.1 Selection of diluent

[0076] Table 1 The dissolution of enalapril maleate and folic acid in different diluents

[0077]

[0078] It can be seen from Table 1 that the solubility of folic acid in phosphate buffer solution / acetonitrile=75:25 and 28.6g / L sodium carbonate solution is not good, and it dissolves completely in 0.01mol / L~0.1mol / L sodium carbonate solution , So you can choose 0.01mol / L~0.1mol / L sodium carbonate solution as diluent.

[0079] 2.2 Selection of testing conditions

[0080] Table 2 Screening of detection conditions for enalapril maleate, folic acid and related substances

[0081]

[0082]

[0083] The sample No. 1 test is the reference substance of enalapril maleate, the sample No. 2 to 3 is the mixed solution of the reference substance of enalapril maleate, the reference substance of folic acid and the reference substance of maleic acid, No. 4~ 7 The tested samples are enalapril maleate reference ...

Embodiment 3

[0088] Example 3 System applicability

[0089] Chromatographic conditions: Diane U3000 high performance liquid chromatography system and workstation; automatic sampling; chromatographic column with octyl-bonded silica gel as filler; UV detection wavelength: 215nm; mobile phase: phosphate buffer solution (0.01mol / L Sodium dihydrogen phosphate solution, adjust the pH to 2.5 with phosphoric acid) and acetonitrile, the gradient program is the same as 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 thinner:

[0091] Take 0.01mol / L sodium dihydrogen phosphate solution, adjust the pH to 6.8 with 1mol / L sodium hydroxide solution, add water to make the volume to 1L, as a phosphate buffer solution.

[0092] Take 90mL of phosphate buffer solution and 10mL of acetonitrile, shake well, as a diluent.

[0093] Preparation of positioning solution:

[0094] Take the folic acid reference substance, accurately weigh it, disso...

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Abstract

The invention provides an analytic detection method for simultaneous determination of enalapril maleate-folate and relevant substances thereof. According to the method, gradient elution is performed through a high-performance liquid chromatograph by using octyl bonded silica gel as a filler and using a phosphate buffer solution with pH ranging from 2.0 to 3.0 and acetonitrile as mobile phases, wherein detection wavelength ranges from 210nm to 220nm, and column temperature ranges from 40 DEG C to 60 DEG C. Through the method, effective separation of all impurities is realized by the adoption ofgradient elution, the separation degree at each absorption peak is greater than 5, feeding precision is good, and RSD is smaller than 1%; and the method is good in durability, and the system applicable solution is good in stability.

Description

Technical field [0001] The invention belongs to the field of pharmaceutical analysis, and specifically relates to a separation and detection method for a composition containing an angiotensin converting enzyme inhibitor and related substances, and in particular to a separation and detection method for enalapril maleate folic acid and related substances. Background technique [0002] The main risk factors for stroke are hypertension, homocysteine ​​(homocysteine, Hcy), abnormal blood sugar, dyslipidemia, etc. Among them, the intervention of hypertension and Hcy has the greatest impact on stroke. An epidemiological survey of common risk factors for cardiovascular and cerebrovascular diseases shows that the prevalence of hypertension, hyperglycemia and high cholesterol in the Chinese population is significantly lower than that in the United States, but the Hcy level is 50% higher than that of the American population. The proportion of Chinese hypertensive patients with elevated plas...

Claims

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Application Information

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IPC IPC(8): G01N30/02G01N30/06
CPCG01N30/02G01N30/06
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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