Method for detecting landiolol hydrochloride optical isomers by high efficiency liquid chromatography

A technology of landiolol hydrochloride and high performance liquid chromatography, which is applied in the field of detecting the optical isomers of landiolol hydrochloride, can solve the problems of unsuitable target detection substance, influence of detection results and the like

Active Publication Date: 2010-10-13
南京海辰药业股份有限公司
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  • Summary
  • Abstract
  • Description
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  • Application Information

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Problems solved by technology

Many isomers are separated by high-performance liquid chromatography, but factors such as mobile phase, solvent, column tem...

Method used

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  • Method for detecting landiolol hydrochloride optical isomers by high efficiency liquid chromatography
  • Method for detecting landiolol hydrochloride optical isomers by high efficiency liquid chromatography
  • Method for detecting landiolol hydrochloride optical isomers by high efficiency liquid chromatography

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Embodiment 1

[0016] Instrument: SHIMADZU LC-10AT high performance liquid chromatograph, SPD-10Avp ultraviolet detector, OV-100 column thermostat;

[0017] Chromatographic column: Daicel Chralcel OJ-H chromatographic column (0.46×25cm, 5μm);

[0018] Mobile phase: n-hexane-isopropanol-diethylamine (80:20:0.1)

[0019] Column temperature: 35°C

[0020] Flow rate: 1.0ml / min

[0021] Detection wavelength: 220nm.

[0022] Preparation of Positioning Solution 1: Accurately weigh an appropriate amount of isomer A of Landil Hydrochloride, dissolve and dilute to 2 mg / ml with isopropanol-methanol (50:50);

[0023] Preparation of positioning solution 2: Accurately weigh an appropriate amount of isomer B of Landil hydrochloride, dissolve and dilute to 2 mg / ml with isopropanol-methanol (50:50);

[0024] Preparation of positioning solution 3: Accurately weigh an appropriate amount of isomer C of Landil hydrochloride, dissolve and dilute to 2 mg / ml with isopropanol-methanol (50:50);

[0025] Preparat...

Embodiment 2

[0028] Instrument: SHIMADZU LC-10AT high performance liquid chromatograph, SPD-10Avp ultraviolet detector, OV-100 column thermostat;

[0029] Chromatographic column: AE.Lichrom OJ-H chromatographic column (0.46×25cm, 5μm);

[0030] Mobile phase: n-hexane-isopropanol-diethylamine (82:18:0.1)

[0031] Column temperature: 35°C

[0032] Flow rate: 1.0ml / min

[0033] Detection wavelength: 220nm.

[0034] Preparation of Positioning Solution 1: Accurately weigh an appropriate amount of isomer A of Landil Hydrochloride, dissolve and dilute to 2 mg / ml with isopropanol-methanol (50:50);

[0035] Preparation of positioning solution 2: Accurately weigh an appropriate amount of isomer B of Landil hydrochloride, dissolve and dilute to 2 mg / ml with isopropanol-methanol (50:50);

[0036] Preparation of positioning solution 3: Accurately weigh an appropriate amount of isomer C of Landil hydrochloride, dissolve and dilute to 2 mg / ml with isopropanol-methanol (50:50);

[0037] Preparation o...

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Abstract

The invention provides a method for detecting landiolol hydrochloride optical isomers by a high efficiency liquid chromatography, comprising the following steps: (1) configuring chromatographic conditions: a chromatographic column adopting silica gel the surface of which is coated with cellulose tris(4-methylbenzoate) is a fixed phase chiral column; a mobile phase is normal hexane-isopropanol-diethylamine; and the detection wave length is 200nm-240nm; (2) adopting organic solvent to prepare a sample into solution containing 0.5-5.0mg/ml of landiolol hydrochloride; and (3) determining and recording chromatogram. The separating degrees of landiolol hydrochloride and landiolol hydrochloride isomers A, B, C reached by the determination method of the invention can reach 1.5-3.9, which conforms to the requirement of Chinese pharmacopoeia. The method provided by the invention can be used for quantifying the landiolol hydrochloride optical isomers.

Description

technical field [0001] The invention relates to a method for detecting optical isomers of Landiolol Hydrochloride by high performance liquid chromatography, more specifically detecting hydrochloric acid in the production process of Landiolol Hydrochloride or in Landiolol Hydrochloride products Methods for Landyrolol A Isomer (Isomer A), Landyrolol Hydrochloride B Isomer (Isomer B) and Landyrolol Hydrochloride C Isomer (Isomer C). [0002] Background technique [0003] Landisolol hydrochloride is a new compound obtained by structural improvement on the basis of esmolol hydrochloride, and its chemical name is 4-[(2S)-2-hydroxyl-3-[[2-[(4-morpholine Formyl)amino]ethyl]amino]propoxy]phenylpropanoic acid 4-[(4S)-2,2-dimethyl-1,3-dioxacyclo]methyl ester hydrochloride, molecular formula: C 25 h 39 N 3 0 8 ·HCl, molecular weight: 546.05, with selectivity β 1 Receptor blocking effect, no intrinsic sympathomimetic activity and membrane stabilizing effect. The mechanism of act...

Claims

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Application Information

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IPC IPC(8): G01N30/02C07D317/24
Inventor 冒宜兰姚晓敏冯明声倪桃郑文艳张璐曹于平
Owner 南京海辰药业股份有限公司
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