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Method for determining content of hyodeoxycholic acid in Beiling capsules through HPLC (High Performance Liquid Chromatography)-ELSD (Evaporative Light Scattering Detector) method

A technology of hyodeoxycholic acid and its determination method, which is applied in the field of content determination, can solve problems such as poor repeatability, insufficient sensitivity, and many interferences, and achieve the effects of high recovery rate, high sensitivity, and guaranteed safety

Inactive Publication Date: 2014-10-08
SHANGHAI LEIYUNSHANG PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

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Problems solved by technology

[0003] Thin-layer scanning has its own defects, including poor repeatability, a lot of interference, and insufficient sensitivity.

Method used

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  • Method for determining content of hyodeoxycholic acid in Beiling capsules through HPLC (High Performance Liquid Chromatography)-ELSD (Evaporative Light Scattering Detector) method
  • Method for determining content of hyodeoxycholic acid in Beiling capsules through HPLC (High Performance Liquid Chromatography)-ELSD (Evaporative Light Scattering Detector) method
  • Method for determining content of hyodeoxycholic acid in Beiling capsules through HPLC (High Performance Liquid Chromatography)-ELSD (Evaporative Light Scattering Detector) method

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Experimental program
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Embodiment 1

[0048] Specific research on the content determination method of the active ingredient hyodeoxycholic acid in Beiling Capsules by HPLC-ELSD method:

[0049] 1 Instruments and materials

[0050] 1.1 Instrument

[0051] Agilent1100 high performance liquid chromatography, ELSD detector, ChemStation B.03.01 chromatographic workstation (Agilent Technologies); Milli-Q ultrapure water machine (Milli-Pore); CQ-250 ultrasonic cleaner (Shanghai Xinchao Ultrasonic Instrument Co., Ltd.) ; BS224S electronic balance (Sartorius).

[0052] 1.2 Materials

[0053] Hyodeoxycholic acid (batch number: 100087-200610, purity 97.3%, purchased from China Institute for the Control of Pharmaceutical and Biological Products); samples of Beiling capsules, a total of 16 batches, Shanghai Leiyunshang Pharmaceutical Co., Ltd.

[0054] Reagents: acetonitrile (HPLC grade, Merck); formic acid, methanol (AR, Sinopharm Chemical Reagent Co., Ltd.); ultrapure water, self-made in the laboratory.

[0055] 2 Determ...

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Abstract

The invention discloses a method for determining the content of hyodeoxycholic acid in Beiling capsules through an HPLC(High Performance Liquid Chromatography)-ELSD (Evaporative Light Scattering Detector) method. The method disclosed by the invention is characterized by comprising the following steps: (1) preparation of a sample, namely preparing hyodeoxycholic acid and Beiling capsule samples, and preparing a test solution from Beiling capsules; (2) HPLC, wherein the flowing phase is acetonitrile-0.05%-0.15% acid solution, the weight percentage of the chromatographic column to the moving phase is (50-75) to (25-50), the flow velocity is 1.0ml.min<-1>, and the sample introduction volume is 20mu l; and (3) detection, wherein an ELSD detector takes air as a carrier gas, the temperature of a drift tube starts from 90 DEG C, once detection is conducted every 5DEG C, the air flow velocity is 1.7-3.0L.min<-1>, and calculation is conducted according to the peak area of hyodeoxycholic acid, the separation degree is not lower than 2.0, and a theoretical plate is not lower than 3000. The method can be used for determining the content of hyodeoxycholic acid, is good in specificity, durability, precision and accuracy, and is applicable to control on the total mass of Beiling capsules.

Description

technical field [0001] The invention relates to a content determination method, in particular to an HPLC-ELSD method for determining the content of hyodeoxycholic acid, an active ingredient in Beiling capsules, and belongs to the technical fields of drug quality standards, analytical chemistry and drug analysis. Background technique [0002] The content determination method of active ingredient hyodeoxycholic acid in Beiling Capsules in the existing quality standard is TLC scanning. [0003] Thin-layer scanning has some defects of its own, including poor repeatability, a lot of interference, and insufficient sensitivity. Contents of the invention [0004] The object of the present invention is to provide a HPLC-ELSD method for determining the content of the active ingredient hyodeoxycholic acid in Beiling capsules, so as to overcome the above-mentioned shortcomings and deficiencies in the prior art. It is applicable to the technical fields of pharmaceutical quality standa...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): G01N30/88G01N30/06
Inventor 钱湧胡馨张赟郭美兰
Owner SHANGHAI LEIYUNSHANG PHARMA
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