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Method for determining content of phenol in iron dextran injection liquid

A technology for the determination of iron dextran, applied in the field of analytical chemistry, can solve the problems of unregulated phenol content and no phenol, and achieve good peak shape

Active Publication Date: 2017-03-22
河北远征药业有限公司
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  • Abstract
  • Description
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  • Application Information

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Problems solved by technology

The United States Pharmacopoeia (USP36-NF31) stipulates that the content of phenol in iron dextran injection should not exceed 0.5%. The Chinese Veterinary Pharmacopoeia 2010 Edition contains the quality standards for iron dextran injection, but there is no regulation on the content of phenol
At present, there are no relevant reports on the determination of phenol content in iron dextran injection in domestic literature

Method used

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  • Method for determining content of phenol in iron dextran injection liquid
  • Method for determining content of phenol in iron dextran injection liquid
  • Method for determining content of phenol in iron dextran injection liquid

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Embodiment 1

[0026] 1. Instruments and reagents

[0027] High-performance liquid chromatography (waters-2695, 2489 ultraviolet detector, the United States); analytical balance (Sartorius CPA225D, Sartorius Scientific Instruments (Beijing) Co., Ltd.); ultrasonic cleaner (KQ2200 type, Kunshan Ultrasonic Instrument Co., Ltd.) ; Iron dextran injection (lot number BJ2140902, Hebei Yuanzheng Pharmaceutical Co., Ltd.); phenol reference substance (lot number: 100509-201203, content 100.0%); methanol and acetonitrile were chromatographically pure, and other reagents were analytical grade reagents.

[0028] 2. Chromatographic conditions

[0029] The chromatographic column selects octadecylsilane bonded silica gel column (4.6×250mm×5 μm); the mobile phase volume ratio is methanol:acetonitrile:water=45:25:30 (V / V), and an ultrasonic degasser is used before use Ultrasonic degassing was performed for 30 minutes to remove air bubbles in the mobile phase; the column temperature was 30°C, the detection wa...

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Abstract

The invention discloses a method for determining the content of phenol in an iron dextran injection liquid, and relates to the field of analytical chemistry. The method comprises the following steps: A, preparation of a test sample: precisely measuring to take the iron dextran injection liquid, placing in a volumetric flask, diluting with purified water, shaking evenly, and thus obtaining the test sample; B, preparation of a standard solution: precisely weighing phenol, placing in a volumetric flask, adding water to dissolve, making the volume constant, and then shaking evenly; and then quantitatively weighing the solution, placing in a volumetric flask, diluting with a mobile phase to a scale, shaking evenly, and filtering to obtain the standard solution; and C, high-performance liquid chromatographic determination: quantitatively weighing the same volume of the test sample in the step A and the standard solution in the step B, and carrying out high-performance liquid chromatographic determination, wherein the chromatographic conditions comprise that an octadecyl silane bonded silica gel column is selected as a chromatographic column, the column temperature is 30 DEG C, the mobile phase comprises methanol, acetonitrile and water with the volume ratio of 45:25:30 (V / V), the flow rate is 1.0 ml / min, the detection wavelength is 270 nm, and the sample introduction amount is 10 [mu]L. The method can determine the content of phenol simply, quickly and accurately.

Description

technical field [0001] The invention relates to the field of analytical chemistry, and relates to a method for determining the content of phenol in iron dextran injection. Background technique [0002] Iron Dextran Injection (Iron Dextran Injection) is mainly composed of dextran iron hydroxide complex, which is suitable for severe iron deficiency anemia or iron deficiency anemia that is not suitable for oral administration of iron. The United States Pharmacopoeia (USP36-NF31) stipulates that the content of phenol in iron dextran injection should not exceed 0.5%. The Chinese Veterinary Pharmacopoeia 2010 edition contains the quality standards for iron dextran injection, but there is no regulation on the content of phenol. At present, there are no relevant reports on the determination of phenol content in iron dextran injection in domestic literature. Contents of the invention [0003] The technical problem to be solved by the present invention is to provide a simple, fast ...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): G01N30/88
Inventor 耿智霞贾国宾魏丽娟李金明郭鸿志刘毅刘欣谢艳芳孔瑞岗魏永辉周岩
Owner 河北远征药业有限公司
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