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Method for detecting ethanol and isopropanol in valsartan hydrochlorothiazide

A technology of hydrochlorothiazide and isopropanol, applied in the field of drug analysis, can solve problems such as uncontrolled residual amount, inability to apply valsartan hydrochlorothiazide, human injury, etc., and achieve stable and reliable results, good repeatability and durability, and quality assurance. Effect

Pending Publication Date: 2022-01-18
LUNAN PHARMA GROUP CORPORATION
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Problems solved by technology

[0003] CN111060628A discloses a method for detecting residual solvents, which can continuously detect the residual amounts of seven mailing solvents including acetonitrile, toluene, methanol, ethanol, acetone, ethyl acetate and isopropanol, but this method is only used for tacrolimus medicines The detection of valsartan and hydrochlorothiazide cannot be applied
[0004] CN103698424B discloses a detection method for residues of ethanol and isopropanol, but it is suitable for insoluble aluminum salt medicines, and it cannot be used for valsartan and hydrochlorothiazide
[0005] In view of the fact that excessive residual organic solvents are harmful to the human body, and the 2015 edition of the "Chinese Pharmacopoeia" and the guidelines of the International Conference on Harmonization of Technical Requirements for Registration of Human Drugs (ICH) have restrictions on ethanol and isopropanol. However, the current The residual amount of ethanol and isopropanol in valsartan hydrochlorothiazide has not been controlled in the standard, therefore, a method for detecting the content of ethanol and isopropanol must be established

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  • Method for detecting ethanol and isopropanol in valsartan hydrochlorothiazide
  • Method for detecting ethanol and isopropanol in valsartan hydrochlorothiazide
  • Method for detecting ethanol and isopropanol in valsartan hydrochlorothiazide

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Embodiment 1

[0108] Instruments and conditions: Shimadzu chromatography system, hydrogen flame ionization detector, chromatographic column: TRACE TR-WAX (30m×0.32mm, 0.25μm); detector temperature: 280°C; inlet temperature: 200°C; with nitrogen It is carrier gas; flow rate is 3ml / min; headspace sample injection, headspace temperature 100°C, headspace time 30min; initial column temperature: 45°C.

[0109] The temperature programmed elution settings were:

[0110]

[0111] Determination: Take an appropriate amount of ethanol and isopropanol reference substance, add water to dissolve, prepare a reference substance solution containing 0.5 mg of ethanol and isopropanol per 1 ml, take 2 ml and place it in a 20 ml headspace bottle, seal it, and use it as a reference substance solution , determined according to the above-mentioned chromatographic conditions, and record the chromatograms. GC chart attached Figure 5 .

[0112] Depend on Figure 5 It can be seen that the retention time of etha...

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Abstract

The invention belongs to the field of pharmaceutical analysis, and relates to a method for simultaneously detecting ethanol and isopropanol in a valsartan hydrochlorothiazide preparation, which adopts a gas chromatography method for detection, adopts a headspace sampling mode for sampling, takes nitrogen as carrier gas, adopts a chromatographic column with polyethylene glycol as a stationary phase, adopts a hydrogen flame ionization detector as a detector type, and adopts programmed heating. The detection method can effectively detect the content of ethanol and isopropanol in valsartan hydrochlorothiazide, has the advantages of high sensitivity, high degree of separation, good repeatability and durability, simple operation and stable and reliable result, can be used for controlling ethanol and isopropanol in valsartan hydrochlorothiazide, and provides an effective guarantee for the quality of a final finished product.

Description

technical field [0001] The invention relates to a method for detecting solvent residues in valsartan hydrochlorothiazide raw materials and preparations, in particular to a method for detecting ethanol and isopropanol in valsartan hydrochlorothiazide raw materials and preparations by using gas chromatography, and belongs to the field of drug analysis. Background technique [0002] Valsartan is an angiotensin II receptor antagonist antihypertensive drug. It can be used for various types of hypertension and has a good protective effect on the heart, brain and kidney. It does not affect the heart rhythm while lowering blood pressure, has very few side effects, has good safety and tolerance, and belongs to one of the five classic antihypertensive drugs. Combined use with hydrochlorothiazide will have a more significant curative effect. In addition to lowering the blood pressure of patients, it can also help prevent left ventricular remodeling and reduce proteinuria. At present, t...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): G01N30/02G01N30/30
CPCG01N30/02G01N30/30
Inventor 张贵民房兆营杨昆昊
Owner LUNAN PHARMA GROUP CORPORATION
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