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High performance liquid chromatography detection method for minocycline hydrochloride and impurities thereof

A technology of high-performance liquid chromatography and minocycline hydrochloride, which is applied in the direction of measuring devices, instruments, scientific instruments, etc., can solve problems such as poor measurement accuracy, large damage to the chromatographic system, and rapid decline in chromatographic column efficiency.

Active Publication Date: 2020-10-30
武汉药品医疗器械检验所
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Among them, the ChP2015 method cannot effectively separate impurity G and minocycline; other standard methods such as USP42 have unsatisfactory separation effects on impurity C and H, and have high requirements for chromatographic columns, and even require specific chromatographic columns, and the concentration of oxalate in the mobile phase is relatively high. High, easy to precipitate, resulting in system instability and poor measurement accuracy; the current standard method contains a large amount of N,N-dimethylformamide in the mobile phase, which will cause great damage to the chromatographic system, and the column efficiency of the chromatographic column will drop rapidly. The service life is obviously shortened, and the analysis cost is increased, and the economic benefit is not high

Method used

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  • High performance liquid chromatography detection method for minocycline hydrochloride and impurities thereof
  • High performance liquid chromatography detection method for minocycline hydrochloride and impurities thereof
  • High performance liquid chromatography detection method for minocycline hydrochloride and impurities thereof

Examples

Experimental program
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Effect test

Embodiment 1

[0031] 1. Chromatographic conditions

[0032] Chromatographic column: Welch Ultimate XB-C8 chromatographic column (200mm×4.6mm, 5μm);

[0033] Mobile phase: acetate buffer [0.25mol / L ammonium acetate solution-0.1mol / L disodium edetate-triethylamine (100:10:1), adjust the pH value to 8.0 with glacial acetic acid]] - Acetonitrile (82:18);

[0034] Flow rate: 1.2ml / min;

[0035] Column temperature: 30°C;

[0036] Wavelength: 280nm.

[0037] 2. Preparation of the solution (operation in the dark)

[0038] ① For the test solution, take the content of this product, grind it finely, accurately weigh an appropriate amount, add water to dissolve and dilute to make a solution containing about 0.5 mg of minocycline per 1 ml, shake well, and filter.

[0039] ②Precisely measure an appropriate amount of the test solution for the control solution, and quantitatively dilute it with water to make a solution containing about 5 μg of minocycline per 1 ml.

[0040] ③ System Suitability Solut...

experiment example

[0054] According to the method described in Example 1, 3 batches of minocycline hydrochloride samples from a certain pharmaceutical manufacturer were inspected for related substances, and the results showed that impurities A, B, C, E, F, G, and H were all detected.

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Abstract

The invention discloses a high performance liquid chromatography detection method for minocycline hydrochloride and impurities thereof. A mobile phase used in the method is a mixed solution of an acetate buffer solution and acetonitrile in a volume ratio of (75-85): 18, and the acetate buffer solution is composed of 0.2-0.3 mol / L of an ammonium acetate solution, 0.08-0.12 mol / L of disodium ethylene diamine tetraacetate and triethylamine in a volume ratio of (95-105): (8-12): 1. According to the method, minocycline hydrochloride can be effectively separated from common impurities A, B, C, E, F,G and H, meanwhile, damage of the mobile phase to a chromatographic system is reduced, and economic benefits are improved.

Description

【Technical field】 [0001] The invention relates to the field of drug analysis, in particular to a high performance liquid chromatography detection method for minocycline hydrochloride and its impurities. 【Background technique】 [0002] Minocycline hydrochloride, also known as minocycline hydrochloride, chemically named [4S-(4α,4aα,5aα,12aα)]-4,7-bis(dimethylamino)-1,4, 4a,5,5a,6,11,12a-octahydro-3,10,12,12a-tetrahydroxy-1,11-dioxo-2-tetracenecarboxamide hydrochloride, belonging to the broad-spectrum tetracyclines Antibiotics are mainly used for Escherichia coli, Bacillus aerogenes, Shigella, Haemophilus influenzae, Klebsiella, Salmonella and other bacteria, as well as mycoplasma, chlamydia and rickettsia, etc. to cause infections. Minocycline hydrochloride has good broad-spectrum antibacterial properties, high strength, high fat solubility, and good penetration in tissues and body fluids. It has become one of the most widely used tetracycline antibiotics in clinical practice...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): G01N30/02G01N30/06G01N30/86
CPCG01N30/02G01N30/06G01N30/86G01N2030/065
Inventor 汪鑫陈蓉付丽娟晏菊姣卢劲涛陈路
Owner 武汉药品医疗器械检验所
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