Method for determining impurity F in captopril tablets through high performance liquid chromatography

A technology of high-performance liquid chromatography and captopril tablets, which is applied in the field of high-performance liquid chromatography for the determination of impurity F in captopril tablets, can solve the problems of cumbersome operation, poor repeatability, and unstable measurement results, and achieve separation Good precision and good effect

Active Publication Date: 2018-08-21
ZHENGZHOU TAIFENG PHARMA CO LTD
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  • Abstract
  • Description
  • Claims
  • Application Information

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Problems solved by technology

[0005] During the research and development of generic drugs for Captopril Tablets, it is necessary to study the impurity F in Captopril Tablets. The operation is cumbersome, the measurement results are unstable, and the repeatability is poor

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  • Method for determining impurity F in captopril tablets through high performance liquid chromatography
  • Method for determining impurity F in captopril tablets through high performance liquid chromatography
  • Method for determining impurity F in captopril tablets through high performance liquid chromatography

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Embodiment 1

[0044] A method for the determination of impurity F in captopril tablets by high performance liquid chromatography, comprising the steps:

[0045] (1) Preparation of captopril impurity F stock solution

[0046] Weigh 5mg of captopril impurity F, place it in a 50ml measuring bottle, add absolute ethanol to dissolve and dilute to the mark, shake well, and use it as captopril impurity F stock solution;

[0047] (2) Preparation of system suitability solution

[0048] Weigh 25mg of captopril reference substance, put it in a 10ml measuring bottle, add (1) 0.5ml, then add 4.5ml of absolute ethanol to dissolve, then dilute to the mark with n-hexane, shake well, and use it as a system suitability solution;

[0049] (3) Preparation of the test solution

[0050] Weigh an appropriate amount of fine powder of captopril tablets (approximately equivalent to 25mg of captopril), put it in a 10ml measuring bottle, add about 5ml of absolute ethanol, extract by ultrasonic vibration for 5min, le...

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Abstract

The invention discloses a method for determining an impurity F in captopril tablets through high performance liquid chromatography and belongs to the technical field of pharmaceutical analysis. Detection is performed under the conditions as follows: an amylase-tris(5-chloro-2-methyl phenyl carbamate) coated chromatographic column is used, normal hexane-absolute ethyl alcohol-trifluoroacetic acid serves as a mobile phase, a volume ratio of the normal hexane to absolute ethyl alcohol to trifluoroacetic acid is 80:20:0.1, a detection wavelength is 215nm, flow velocity is 1ml / min, a column temperature is 35 DEG C and a sample amount is 20[mu]l. A structural formula of the impurity F is as shown in the description. According to the method disclosed by the invention, the content of the impurityF in the captopril tablets can be quantitatively determined, so that the quality of the captopril tablets is effectively controlled. According to the method provided by the invention, the captopril and the impurity F can be proved to be effectively separated in a system suitability solution, and the method has high precision and high separation degree. A signal to noise ratio of a self-contrast solution is more than 10, and if the sample contains the impurity F, the impurity F can be detected.

Description

technical field [0001] The invention belongs to the technical field of drug analysis, in particular to a method for measuring impurity F in captopril tablets by high performance liquid chromatography. Background technique [0002] Captopril is the first angiotensin-converting enzyme inhibitor (ACEI) to be discovered. Since it came out in the 1990s, it has turned from a special drug for the treatment of high blood pressure to a drug for the treatment of other cardiovascular diseases, rheumatoid arthritis and other diseases. The development of clinical medication has great clinical value. [0003] Captopril, also known as mercaptomethylpropaproline, has a structural formula such as figure 1 , which has a total of 15 impurities from impurity A to impurity 0 in the European Pharmacopoeia, among which impurity F is more special, and its structural formula is as follows figure 2 ; by pair figure 1 , figure 2 It can be seen from the comparison that impurity F is the diastereo...

Claims

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Application Information

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IPC IPC(8): G01N30/02
CPCG01N30/02
Inventor 沙薇郑海杰李婷
Owner ZHENGZHOU TAIFENG PHARMA CO LTD
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