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Method for determining content of cisatracurium besylate of raw materials by HPLC (High Performance Liquid Chromatography)

A technology for the content of cisatracurium besylate and its content is applied in the directions of measuring devices, material separation, and analysis of materials, which can solve the problems of long time-consuming detection of cisatracurium besylate and reduce inspection costs, consumption, and The effect of prolonging life

Inactive Publication Date: 2016-01-27
SHANGHAI PHARMA DONGYING JIANGSU PHARMA CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

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Problems solved by technology

[0005] Purpose of the invention: In order to solve the deficiencies in the prior art, the present invention provides a method for determining the content of cisatracurium besylate in raw materials by HPLC, so as to solve the problem that the detection time of cisatracurium besylate content is too long, while taking into account Simplify the process of preparing mobile phase, save mobile phase consumption, and reduce inspection costs

Method used

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  • Method for determining content of cisatracurium besylate of raw materials by HPLC (High Performance Liquid Chromatography)
  • Method for determining content of cisatracurium besylate of raw materials by HPLC (High Performance Liquid Chromatography)
  • Method for determining content of cisatracurium besylate of raw materials by HPLC (High Performance Liquid Chromatography)

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Embodiment 1

[0058] The present invention has carried out relevant content methodology verification, which shows that the method has high sensitivity, good specificity, and accurate and reliable results. The relevant data are as follows:

[0059]

[0060]

[0061] The specific operation steps of the verification experiment are as follows:

[0062] (1) Injection repeatability

[0063] Accurately weigh 10 mg of cis-atracurium besylate reference substance, put it in a 25 ml measuring bottle, add mobile phase to constant volume to the mark, shake well, and use it as the test solution. Precisely measure 20 μl of the test solution, inject it into the liquid chromatograph, repeat the injection 5 times, and record the chromatogram.

[0064]

[0065] The RSD value of the peak area of ​​cisatracurium in 5 injections was less than 2.0%, and the injection repeatability was good.

[0066] (2) System adaptability

[0067] Accurately weigh 10 mg of atracurium besylate reference substance, pu...

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Abstract

The invention discloses a method for determining content of cisatracurium besylate of raw materials by an HPLC (High Performance Liquid Chromatography). New chromatographic conditions for determining the content of the cisatracurium besylate by the HPLC are established; an isocratic elution manner is adopted so that the preparation of a mobile phase is changed to one portion from two portions and the method is relatively convenient and saves time; and meanwhile, the isocratic elution is good for prolonging the service life of an instrument and a chromatographic column. According to the method, time consumed by single-needle sample feeding is 25 minutes and the checking efficiency is improved; and the consumption of the mobile phase is reduced so that the checking cost is reduced.

Description

technical field [0001] The invention belongs to the field of drug analysis, in particular to a method for determining the content of cisatracurium besylate as a raw material by HPLC. Background technique [0002] The 2010 edition pharmacopoeia measures the chromatographic condition of the high-performance liquid chromatography of besylate cisatracurium content as: be filler with octadecyl bonded silica gel; With 1.02% potassium dihydrogen phosphate buffer solution (adjust pH to 3.1)-methanol-acetonitrile (75:5:20) as mobile phase A, 1.02% potassium dihydrogen phosphate buffer solution (adjust pH to 3.1 with phosphoric acid)-methanol-acetonitrile (50:30:20) as mobile phase B , according to gradient elution; detection wavelength is 280nm. [0003] [0004] This method uses gradient elution, which requires the instrument to have good degassing effect and the chromatographic column to withstand high pressure. Moreover, this method takes a long time, 60 minutes for single-ne...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): G01N30/88
Inventor 顾培姜丽华张耀华王坚陈亚朱赟
Owner SHANGHAI PHARMA DONGYING JIANGSU PHARMA CO LTD
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