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HPLC-ELSD detection method of gentamicin c component in gentamicin procaine vitamin b12 capsules

A technology of gentamicin and procaine, applied in measurement devices, material separation, analysis of materials, etc., can solve the problems of lack of inspection items, hidden dangers of product quality control, etc., and achieve stable inspection methods, quality control, and strong The effect of practicality

Active Publication Date: 2022-04-01
广西壮族自治区食品药品检验所
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  • Abstract
  • Description
  • Claims
  • Application Information

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Problems solved by technology

Gentamicin sulfate is one of the main medicinal ingredients of this product, and the lack of corresponding inspection items in the standard is undoubtedly a major hidden danger for product quality control

Method used

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  • HPLC-ELSD detection method of gentamicin c component in gentamicin procaine vitamin b12 capsules
  • HPLC-ELSD detection method of gentamicin c component in gentamicin procaine vitamin b12 capsules
  • HPLC-ELSD detection method of gentamicin c component in gentamicin procaine vitamin b12 capsules

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Experimental program
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Embodiment 1

[0032] One, the HPLC-ELSD detection method of gentamicin C component content in a kind of gentamicin procaine vitamin B12 capsule, comprises the following steps:

[0033] (1) Chromatographic conditions and system suitability test:

[0034] Octadecylsilane bonded silica gel was used as filler, Shiseido ACR C18 4.6×250mm 5μm chromatographic column, methanol was used as mobile phase A, 0.02mol / L trifluoroacetic acid was used as mobile phase B, and gradient elution was carried out according to Table 1. The flow rate is 1ml / min, the column temperature is 30°C, the atomization temperature is 70°C, and the air velocity is 1.6SLM. The chromatogram of the gentamicin standard solution should be consistent with the standard spectrum;

[0035]

[0036] (2) Solution preparation:

[0037] Preparation of gentamicin sulfate standard solution

[0038] Take 100mg of gentamicin sulfate standard substance, weigh it accurately, put it in a 10mL measuring bottle, dissolve it with water and dil...

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Abstract

The invention belongs to the field of chemical detection, and in particular relates to an HPLC-ELSD detection method for the content of gentamicin C component in gentamicin procaine vitamin B12 capsules, including (1) chromatographic conditions and system applicability test ( 2) Solution preparation (3) Determination and other steps. The method is simple to operate, has high detection efficiency, small error, and relatively stable test method. The accuracy, precision, specificity, detection limit, and durability of the method all meet the requirements of methodological verification, and have strong practicability. Quickly detect the content of gentamicin C component in gentamicin procaine vitamin B12 capsules, so as to effectively control the quality of gentamicin procaine vitamin B12 capsules.

Description

technical field [0001] The invention belongs to the field of chemical detection, and in particular relates to an HPLC-ELSD detection method for the content of gentamicin C component in gentamicin procaine vitamin B12 capsules. Background technique [0002] Gentamicin Procaine Vitamin B12 Capsules (formerly known as Gastritis Capsules, also known as Gentamicin Procaine Capsules, hereinafter referred to as "capsules")) is composed of gentamicin sulfate, procaine hydrochloride It is a compound oral preparation composed of factor, vitamin B12 and appropriate amount of auxiliary materials. Among them, gentamicin sulfate is an aminoglycoside antibiotic, which has antibacterial effects on various Gram-negative bacteria, Gram-positive bacteria and Helicobacter pylori, can inhibit Helicobacter pylori, and exert local bactericidal effect in the stomach; Luca is a local anesthetic, which can seal the nerve endings on the damaged mucosal surface, block the stimulation of the lesion to ...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): G01N30/02G01N30/06
Inventor 卢日刚朱健萍朱荣赵庄黄丽丽陈瀚谭菊英邓鸣
Owner 广西壮族自治区食品药品检验所
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