High-performance liquid phase detection method of carbamazepine

A carbamazepine and high-performance liquid phase technology, applied in the field of high-performance liquid phase detection of carbamazepine, can solve the problems of low quantitative analysis accuracy and accuracy, baseline drift, and inaccurate integration, etc., to achieve convenient and fast processing , good linear relationship, and the effect of improving detection efficiency

Inactive Publication Date: 2019-06-14
上海药明康德新药开发有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

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Problems solved by technology

The inventor measures the content of carbamazepine and its impurities according to this method, and finds that the baseline has drifted during the elution of the HPLC chromatogram, and the integration is inaccurate. The precision and accuracy are not high when it is used for quantitative analysis, and the detection needs more than 65min , time-consuming

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  • High-performance liquid phase detection method of carbamazepine
  • High-performance liquid phase detection method of carbamazepine
  • High-performance liquid phase detection method of carbamazepine

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Embodiment 1

[0066] Mobile phase A is a mixed solution of formic acid-ammonium acetate aqueous solution / acetonitrile (95 / 5; v / v), the volume concentration of formic acid in the aqueous solution is 0.025%, and the concentration of ammonium acetate in the aqueous solution is 1mM; Mobile phase B is formic acid-ammonium acetate A mixed solution of acetonitrile solution / water (95 / 5; v / v), the volume concentration of formic acid in the acetonitrile solution is 0.025%, and the concentration of ammonium acetate in the acetonitrile solution is 1 mM.

[0067] After four sample injections under this method, the HPLC spectrum is as follows Figure 2-5 As shown, the baseline is stable, the repeatability is good, all the peaks can be extracted within 3 minutes, the retention time of carbamazepine is 2.043-2.045 minutes, the retention time of process impurities is 0.750-0.847, and the resolution is greater than 1.5, and the number of theoretical plates is 21509.

Embodiment 2

[0069] Mobile phase A is a mixed solution of formic acid-ammonium acetate aqueous solution / acetonitrile (95 / 5; v / v), the volume concentration of formic acid in the aqueous solution is 0.01%, and the concentration of ammonium acetate in the aqueous solution is 0.5mM; Mobile phase B is formic acid-acetic acid A mixed solution of ammonium in acetonitrile solution / water (95 / 5; v / v), the volume concentration of formic acid in the acetonitrile solution is 0.01%, and the concentration of ammonium acetate in the acetonitrile solution is 0.5 mM.

[0070] Under this method, the baseline is stable, the retention time of carbamazepine is about 2.045min, and the resolution is 13.505.

Embodiment 3

[0072] Mobile phase A is a mixed solution of formic acid-ammonium acetate aqueous solution / acetonitrile (95 / 5; v / v), the volume concentration of formic acid in the aqueous solution is 0.03%, and the concentration of ammonium acetate in the aqueous solution is 1.5mM; Mobile phase B is formic acid-acetic acid A mixed solution of ammonium in acetonitrile solution / water (95 / 5; v / v), the volume concentration of formic acid in the acetonitrile solution is 0.03%, and the concentration of ammonium acetate in the acetonitrile solution is 1.5 mM.

[0073] Under this method, the baseline is stable, the retention time of carbamazepine is about 2.044min, and the resolution is 13.443.

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Abstract

The invention discloses a high-performance liquid phase detection method of carbamazepine. The high-performance liquid phase detection method of carbamazepine adopts a reversed phase C18 chromatographic column and a DAD detector; a mobile phase A is a mixed solution of formic acid-ammonium acetate aqueous solution and acetonitrile; a mobile phase B is a mixed solution of formic acid-ammonium acetate in acetonitrile solution and water; and gradient elution is used. Using the method disclosed by the invention to inject a sample 3 to 5 [Mu]l, the carbamazepine and related substances can be effectively detected; the resolution R can reach 1.5 or more; and the base line of HPLC spectrum is stable and does not drift. The detection time of the high-performance liquid phase detection method of carbamazepine is short, and the high-performance liquid detection process can be completed in only 3 minutes; the high-performance liquid phase detection method of carbamazepine greatly reduces the sample consumption, improves the detection efficiency, and is suitable for high-throughput screening, which can save solvent and reduce cost; and the method disclosed by the invention is used for the determination of the carbamazepine content, which has good linear relationship and high reproducibility, and has significances in the research of raw material medicine, preparation quality and pharmacokinetic quantitative research.

Description

technical field [0001] The invention relates to the technical field of drug analysis, in particular to a high-efficiency liquid phase detection method for carbamazepine. Background technique [0002] Carbamazepine is a class of anti-epileptic and mood-stabilizing drugs, and it is also effective for grand mal seizures, partial seizures and mixed epilepsy. Mainly used in the treatment of epilepsy, bipolar disorder and trigeminal neuralgia. Carbamazepine has many side effects, including: life-threatening allergic reactions, toxicity to the trigeminal nerve, and possible serious damage to the skin and internal organs, so it is very important to monitor the patient's blood drug levels during treatment. [0003] At present, the commonly used methods for detecting carmenzepine blood drug concentration in plasma include: ultraviolet spectrophotometry, fluorescence polarization immunoassay, high performance liquid chromatography, gas chromatography-mass spectrometry, liquid chromato...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): G01N30/89
Inventor 成立炜汤城
Owner 上海药明康德新药开发有限公司
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