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Method for determining procaine hydrochloride content in gentamycin procaine vitamin B12 particle by high performance liquid chromatography

A technology of high performance liquid chromatography and procaine hydrochloride, which is applied in the field of drug content determination and achieves the effects of short test time, accurate determination results and simple method

Inactive Publication Date: 2011-10-26
NINGBO SHUANGWEI PHARMA
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  • Abstract
  • Description
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Problems solved by technology

However, no high-performance liquid chromatography method has been found for the determination of gentamicin procaine vitamin B 12 Record or application of procaine hydrochloride content in granules

Method used

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  • Method for determining procaine hydrochloride content in gentamycin procaine vitamin B12 particle by high performance liquid chromatography
  • Method for determining procaine hydrochloride content in gentamycin procaine vitamin B12 particle by high performance liquid chromatography
  • Method for determining procaine hydrochloride content in gentamycin procaine vitamin B12 particle by high performance liquid chromatography

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Embodiment Construction

[0014] 1. Instruments and reagents

[0015] Using LC-10ATvp Japan Shimadzu high performance liquid chromatography, SPD-10Avp ultraviolet detector, P / N (7725i) manual sampler made in the United States, Zhejiang University N-2000 data workstation, electronic balance for one hundred thousandth analysis scales. The reference substance of procaine hydrochloride was purchased from China Institute for the Control of Pharmaceutical and Biological Products, gentamicin procaine vitamin B 12 Granular samples were self-produced (batch numbers 100501, 100801, and 10090), procaine hydrochloride raw materials were provided by Liaoyuan Baikang Pharmaceutical Co., Ltd. (batch number 090311), acetonitrile was chromatographic grade, water was double distilled water, and others For analytical grade reagents.

[0016] 2. Chromatographic conditions

[0017] The chromatographic column is an octadecylsilane bonded silica gel column with a size of 250×4.60 mm and a filler particle size of 5 μm. Th...

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Abstract

The invention relates to a method for determining the procaine hydrochloride content in a gentamycin procaine vitamin B12 particle by high performance liquid chromatography, and the chromatographic conditions adopted by the method include that: an octadecyl silane bonded silica gel column is employed as a chromatographic column; a mobile phase is prepared by water, acetonitrile and triethylamine with a volume ratio of 85:15:0.02 and is adjusted by glacial acetic acid to obtain a pH of 3.9; a column temperature is 35 DEG C; a detection wavelength is 292 nm; a flow speed is 1.0 ml / min; and an injection volume is 20 microliter. The determination result of the procaine hydrochloride content in a gentamycin procaine vitamin B12 particle obtained by the method of the invention is accurate and reliable, and the method is simple and scientific. The test time is short; no interference peak appears; the theoretical plate number is up to above 2000; the resolution, the tailing factor, and the asymmetry degree all meet the requirements of Chinese pharmacopoeia; and the detection results is good.

Description

technical field [0001] The invention relates to the field of drug content determination, in particular to a high-performance liquid chromatography method for the determination of gentamicin procaine vitamin B 12 Method for procaine hydrochloride content in granules. Background technique [0002] Gentamicin Procaine Vitamin B 12 The granule is a compound preparation, and its main ingredients are gentamicin sulfate 20mg (20000 units), procaine hydrochloride 0.1g, vitamin B 12 0.02mg. Gentamicin sulfate has antibacterial effects on various Gram-negative bacteria, Gram-positive bacteria and Helicobacter pylori, and its mechanism of action is to inhibit the synthesis of bacterial proteins. Procaine hydrochloride has a local anesthetic effect, and its mechanism of action is to competitively combine with nerve membrane lipoproteins, hinder sodium ions, and hinder the conduction of nerve fibers. Vitamin B 12 It is necessary for the formation of normal epithelial cells of the di...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): G01N30/36G01N30/60G01N30/06
Inventor 艾建高孙伟东
Owner NINGBO SHUANGWEI PHARMA
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