Method for determining content of vitamin B12 in complex vitamin B and diclofenac sodium tablet through high performance liquid chromatography

A technology of high-performance liquid chromatography and diclofenac sodium, which is applied in the direction of measuring devices, instruments, scientific instruments, etc., can solve the problems that do not conform to the thinking logic of trace analysis, difficult to purify the sample solution, and cannot be detected in small quantities, etc., and achieve the detection results Good, short test time, no interference peak effect

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

The method in the above standard has not been tested well. First, it cannot be detected in a small amount. If the sample volume is increased, the sample solution is very difficult to purify, which does not conform to the logic of micro-analysis; second, although the customer service operation method is purified and processed sample solution, but vitamin B 1 with vitamin B 6 and diclofenac sodium have interference peaks, unable to give vitamin B 1 Locating and counting content

Method used

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  • Method for determining content of vitamin B12 in complex vitamin B and diclofenac sodium tablet through high performance liquid chromatography

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Embodiment Construction

[0017] 1. Instruments and reagents

[0018] LC-10ATvp Japanese Shimadzu high performance liquid chromatograph, SPD-10Avp ultraviolet detector, P / N (7725i) manual sampler made in the United States, Zhejiang University N-2000 data workstation, column thermostat, and electronic balance are 100,000 One-third analytical balance, DD80 ultrasonic degasser, 800 centrifuge. Vitamin B 12 The reference substance was purchased from China Institute for the Control of Pharmaceutical and Biological Products (batch number: 100248-200802, for HPLC content determination, content 95.5%), compound vitamin B + diclofenac sodium tablet samples were self-produced (batch number 091011), and methanol was primary chromatographically pure ( Place of Origin: Tianjin Siyou Fine Chemicals Co., Ltd.), water is double distilled water (self-made), and other reagents are analytical grade reagents.

[0019] 2. Chromatographic conditions

[0020] The chromatographic column is an octadecylsilane bonded silica ...

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Abstract

The invention relates to a method for determining content of vitamin B12 in a complex vitamin B and diclofenac sodium tablet through high performance liquid chromatography. The method comprises the following steps of: (1) preparing reference solution under a condition of keeping away from light; (2) removing wrapper of a complex vitamin B and diclofenac sodium tablet sample, porphyrizing the complex vitamin B and diclofenac sodium tablet sample, adding a mobile phase and dissolving the mixture ultrasonically, shaking up, centrifuging and precipitating, taking out liquid supernatant, weighing the liquid supernatant, heating the liquid supernatant to be boiling, and then cooling the liquid supernatant, dripping the mobile phase to recover the weight before boiling, shaking up, and filtering to get a test sample solution; and (3) providing chromatographic conditions, wherein a chromatographic column is selected from a octadecylsilane chemically bonded silica column, a mixture of methyl alcohol and 0.05mol / l monopotassium phosphate solution with volume ratio of 22:78 is used as the mobile phase, the pH value of the monopotassium phosphate solution is 6.4, column temperature is 35 DEG C, detection wavelength is 361nm, flow velocity is 1.0ml / min, and sample size is 20 microliter. The method provided by the invention is accurate, reliable and excellent in determination result, simple, convenient and scientific in means and accordant to requirements of Chinese pharmacopoeia.

Description

technical field [0001] The invention relates to the field of determination of drug content, in particular to a high performance liquid chromatography method for determination of vitamin B in compound vitamin B + diclofenac sodium tablets 12 content method. Background technique [0002] Composite Vitamin B + Diclofenac Sodium Tablets is a product for foreign trade export. Its main market is in Nigeria and other countries on the African continent. It is an international famous brand product in the local area, with an annual sales volume of more than 50 million tablets and a strong price advantage. However, since there is no ready-made statutory inspection standard for this product at home and abroad, only vitamin B can be detected according to the internal standard inspection provided by foreign companies. 1 with vitamin B 6 And the content of diclofenac sodium, vitamin B 12 There is no method to detect and identify the content of the content. [0003] Since there is no wa...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): G01N30/88G01N30/06G01N30/36G01N30/60
Inventor 艾建高孙伟东
Owner NINGBO SHUANGWEI PHARMA
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