Detection method of valsartan enantiomer
An enantiomer, valsartan technology, applied in the field of drug analysis, can solve the problems of poor separation, harsh use conditions of AGP columns, short service life of chromatographic columns, etc., achieving simple operation, stable and reliable results, The effect of low detection limits
Pending Publication Date: 2022-07-01
LUNAN PHARMA GROUP CORPORATION
View PDF0 Cites 1 Cited by
- Summary
- Abstract
- Description
- Claims
- Application Information
AI Technical Summary
Problems solved by technology
[0003] In the existing standard, the Chinese Pharmacopoeia uses the AGP column to systematically detect the content of valsartan enantiomers in reversed-phase liquid chromatography, but the AGP column is used under harsh conditions and the service life of the chromatographic column is short
British Pharmacopoeia and US Pharmacopoeia use normal phase chromatography system, isocratic elution method for detection, the separation between valsartan enantiomers and valsartan is not good
Method used
the structure of the environmentally friendly knitted fabric provided by the present invention; figure 2 Flow chart of the yarn wrapping machine for environmentally friendly knitted fabrics and storage devices; image 3 Is the parameter map of the yarn covering machine
View moreImage
Smart Image Click on the blue labels to locate them in the text.
Smart ImageViewing Examples
Examples
Experimental program
Comparison scheme
Effect test
Embodiment 1
[0096] Instrument and conditions: Agilent 1260 liquid chromatography system, VWD detector, chromatographic column: nanospectral OD-5H column 4.6 × 150 mm, 5 μm; detection wavelength: 227 nm; n-hexane as mobile phase A, with 0.1% trifluoroacetic acid The ethanol is the mobile phase B, gradient elution, the column temperature is 30 °C, the flow rate is 0.8 ml / min, and the injection volume is 10 μl;
[0097] By volume, the gradient elution settings are:
[0098]
[0099] Determination: Take an appropriate amount of valsartan and valsartan enantiomer reference substance, prepare a solution containing about 10 μg / ml each with n-hexane, precisely measure 10 μl and inject it into a liquid chromatograph, and record the chromatogram. HPLC chromatogram is attached Image 6 .
[0100] Depend on Image 6 It can be seen that the retention times of valsartan and valsartan enantiomers are 6.294 min and 8.570 min respectively, the resolution is 4.97, and there is no impurity peak that i...
the structure of the environmentally friendly knitted fabric provided by the present invention; figure 2 Flow chart of the yarn wrapping machine for environmentally friendly knitted fabrics and storage devices; image 3 Is the parameter map of the yarn covering machine
Login to View More PUM
| Property | Measurement | Unit |
|---|---|---|
| wavelength | aaaaa | aaaaa |
| wavelength | aaaaa | aaaaa |
| separation | aaaaa | aaaaa |
Login to View More
Abstract
The invention belongs to the field of pharmaceutical analysis, and relates to a method for detecting valsartan enantiomers, in particular to a method for detecting valsartan enantiomers by high performance liquid chromatography, which is characterized in that a chromatographic column is a chiral column, n-hexane is used as a mobile phase A, ethanol containing 0.1% of trifluoroacetic acid is used as a mobile phase B, gradient elution is performed, and the detection wavelength is 210-270nm. The detection method can effectively detect the content of the enantiomer in the valsartan, is high in sensitivity, high in separation degree, good in repeatability and durability, simple to operate and stable and reliable in result, can be used for controlling the enantiomer in the valsartan, 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 enantiomers in valsartan raw materials and preparations thereof, in particular to a method for detecting enantiomers in valsartan raw materials and preparations by high performance liquid chromatography, It belongs to the field of drug analysis. Background technique [0002] Valsartan, an angiotensin receptor antagonist, can be used for various types of hypertension and has cardio-cerebral-renal protection independent of blood pressure. It was recommended by the 2007 European Guidelines for Hypertension for the following special populations : The preferred antihypertensive drug for elderly patients, diabetic patients, patients with renal insufficiency, stroke patients, coronary heart disease and heart failure patients with hypertension. It can be used routinely in patients with hypertension such as myocardial infarction, heart failure, proteinuria, and diabetes, and can be used in combination with diuret...
Claims
the structure of the environmentally friendly knitted fabric provided by the present invention; figure 2 Flow chart of the yarn wrapping machine for environmentally friendly knitted fabrics and storage devices; image 3 Is the parameter map of the yarn covering machine
Login to View More Application Information
Patent Timeline
Login to View More Patent Type & Authority Applications(China)
IPC IPC(8): G01N30/02
CPCG01N30/02
Inventor 郭小为刘阿利田镇
Owner LUNAN PHARMA GROUP CORPORATION