Method for detecting alpha-tropine in tropisetron hydrochloride injection

A technology of tropisetron hydrochloride and detection method, applied in the directions of measuring devices, instruments, scientific instruments, etc., can solve the problem that the limit analysis of α-tropinol cannot be realized, the control method of α-tropinol is not found, and the sensitivity of the detector can not be realized. Insufficient and other problems, to achieve the effect of fast speed, simple method and high resolution

Inactive Publication Date: 2012-06-13
SHANDONG QIDU PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, α-tropine alcohol has no ultraviolet absorption, and cannot be analyzed using a high-performance liquid chromatograph ultraviolet detector. When using an evaporative light detector and a differential refractive index detector, the limit analysis of α-tropine alcohol cannot be realized. Sensitivity is not enough
As for the sensitive and rapid detection of α-tropine alcohol in Tropisetron Hydrochloride Injection, no control method for α-tropine alcohol in this preparation has been found at home and abroad.

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0020] (1) Preparation of the test solution: accurately measure tropisetron hydrochloride injection in an evaporating dish, then put the evaporating dish into a water bath and evaporate to nearly dry, add methanol-dichloromethane to dissolve and quantitatively dilute to 30mg / mL of the test solution, the volume ratio of methanol and dichloromethane is 1:1;

[0021] (2) Reference substance solution preparation: Accurately weigh α-tropine alcohol reference substance, add methanol-dichloromethane to dissolve and quantitatively dilute to 0.06mg / ml reference substance solution, the volume ratio of methanol and dichloromethane is 1: 1;

[0022] (3) Expansion: Take 15 μl each of the above-mentioned reference solution and the test solution, and spot on the same high-efficiency silica gel GF respectively. 254 On the thin-layer plate, after the chromatography cylinder is developed, take it out and dry it; the developer is methanol-dichloromethane-ammonia; wherein the volume ratio of me...

Embodiment 2

[0027] (1) Preparation of the test solution: accurately measure tropisetron hydrochloride injection in an evaporating dish, then put the evaporating dish into a water bath and evaporate to nearly dry, add methanol-dichloromethane to dissolve and quantitatively dilute to 30mg / mL of the test solution, the volume ratio of methanol and dichloromethane is 1:1;

[0028] (2) Reference substance solution preparation: Accurately weigh α-tropine alcohol reference substance, add methanol-dichloromethane to dissolve and quantitatively dilute to 0.06mg / ml reference substance solution, the volume ratio of methanol and dichloromethane is 1: 1;

[0029] (3) Expansion: Take 15 μl each of the above-mentioned reference solution and the test solution, and spot on the same high-efficiency silica gel GF respectively. 254 On the thin-layer plate, after the chromatography cylinder is developed, take it out and dry it; the developer is methanol-dichloromethane-ammonia; wherein the volume ratio of me...

Embodiment 3

[0034] (1) Preparation of the test solution: accurately measure tropisetron hydrochloride injection in an evaporating dish, then put the evaporating dish into a water bath and evaporate to nearly dry, add methanol-dichloromethane to dissolve and quantitatively dilute to 30mg / mL of the test solution, the volume ratio of methanol and dichloromethane is 1:1;

[0035] (2) Reference substance solution preparation: Accurately weigh α-tropine alcohol reference substance, add methanol-dichloromethane to dissolve and quantitatively dilute to 0.06mg / ml reference substance solution, the volume ratio of methanol and dichloromethane is 1: 1;

[0036] (3) Expansion: Take 15 μl each of the above-mentioned reference solution and the test solution, and spot on the same high-efficiency silica gel GF respectively. 254 On the thin-layer plate, after the chromatography cylinder is developed, take it out and dry it; the developer is methanol-dichloromethane-ammonia; wherein the volume ratio of me...

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Abstract

The invention relates to a detection method of alpha-tropine, especially to a method for detecting alpha-tropine in a tropisetron hydrochloride injection. The method comprises the steps of: respectively preparing a sample solution and a reference solution, dripping the solutions respectively on one high efficiency silica gel GF254 thin-layer plate, and conducting development, then taking out and air drying the thin-layer plate, which is then dyed in a potassium iodobismuthate solution, and finally viewing the result. If the sample solution shows a speckle at the position of alpha-tropine in the reference solution, the sample solution can be determined to contain alpha-tropine, and the content of alpha-tropine is determined through color strength comparison of the speckle shown by the sample solution and the speckle shown by the reference solution. Characterized by high resolution, high sensitivity, simplicity and speediness, etc., the method of the invention can detect alpha-tropine with content less than 0.30 microgram in a tropisetron hydrochloride injection, thus providing guarantee for quality control during tropisetron hydrochloride injection preparation.

Description

technical field [0001] The invention relates to a detection method for α-tropine alcohol, in particular to a detection method for α-tropine alcohol in tropisetron hydrochloride injection. Background technique [0002] Tropisetron is a potent and selective 5HT-3 receptor antagonist developed by Novartis and launched in the UK in 1992 under the trade name Navoban. It is used for the prevention and treatment of nausea and vomiting caused by radiotherapy and chemotherapy. At present, the drug has been marketed in dozens of countries around the world, and its indications have been expanded to prevent and treat nausea and vomiting during radiotherapy and chemotherapy in children, and prevent and treat postoperative nausea and vomiting in adults. [0003] Because of its definite curative effect, tropisetron has been widely used in large and medium-sized hospitals. Faced with a large number of cancer patients undergoing radiotherapy and chemotherapy every year in the country, its m...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): G01N30/90
Inventor 黄国英刘绪贵于海云周海洋刘杰
Owner SHANDONG QIDU PHARMA
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