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Method for separating and detection palonosetron hydrochloride and impurity

A palonosetron hydrochloride impurity, separation method technology, applied in the field of analytical chemistry, to achieve the effect of shortening the separation time

Active Publication Date: 2015-07-08
CHONGQING HUAPONT PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

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Problems solved by technology

Also there is no report on a method for separating the above-mentioned impurities

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  • Method for separating and detection palonosetron hydrochloride and impurity
  • Method for separating and detection palonosetron hydrochloride and impurity
  • Method for separating and detection palonosetron hydrochloride and impurity

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0063] The chromatogram of embodiment 1 palonosetron hydrochloride and 4 kinds of process impurities

[0064] Impurity A is shown in molecular formula I; impurity B is shown in molecular formula II; impurity C is shown in molecular formula III; impurity D is shown in molecular formula IV.

[0065] Preparation of the reference substance mixture of the four impurities: take about 25 mg of the reference substances of impurity A, impurity B, impurity C and impurity D respectively, put them in 25ml measuring bottles, add methanol to dissolve and dilute to the mark, shake well , to obtain impurity A stock solution, impurity B stock solution, impurity C stock solution and impurity D stock solution. Precisely pipette 2.5ml of the above four stock solutions, place them in a 100ml measuring bottle, add diluent to dilute to the mark, and shake well to obtain the reference substance mixture of the four impurities with a concentration of 25 μg / ml.

[0066] The preparation of test sample m...

Embodiment 2

[0071] Example 2 Palonosetron Hydrochloride Injection Auxiliary Materials Influence on the Determination of Palonosetron Hydrochloride

[0072] Take 1 stick of palonosetron hydrochloride injection (manufacturer: Chongqing Huabang Pharmaceutical Co., Ltd.) (containing 0.25 mg of palonosetron hydrochloride) as the test solution.

[0073] Take the test solution, inject samples according to the above chromatographic conditions, record the chromatogram, and carry out the blank excipient test in the same way, the result shows that no other peaks appear in the HPLC spectrum of the blank excipient after 4 minutes, indicating that the blank excipient does not interfere with palonosetron hydrochloride determination, see image 3 , Figure 4 .

[0074] Conclusion: Blank excipients do not interfere with the determination of this product, indicating that the method of the present invention can be used for the quality detection of palonosetron hydrochloride injection. The analysis method...

Embodiment 3

[0075] Example 3 Determination of Oxidative Degradation Products of Palonosetron Hydrochloride

[0076] Take 25mg of palonosetron hydrochloride, accurately weigh it, put it in a 25ml measuring bottle, add 2.0ml of 10% hydrogen peroxide, bathe in water at 60°C for 4 hours, take it out, cool it, dissolve it with a diluent and dilute to the mark, shake it up, and use it as a degradation product solution for measurement.

[0077] Take the solution for the determination of the above-mentioned degradation products and inject samples, record the chromatogram, and do a blank test at the same time, record the chromatogram, such as Figure 5 As shown, the impurity content was calculated according to the area normalization method. The test results are shown in Table 3.

[0078] Table 3 Oxidative Degradation Test Determination Results

[0079]

[0080] Conclusion: Under the condition of oxidative degradation, impurity D was produced in water bath at 60°C for 4 hours, with a level of...

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Abstract

The invention belongs to the field of analytical chemistry, relates to a method for the simultaneous determination of palonosetron hydrochloride and four impurities. In particular, a high performance liquid chromatography method is employed for the simultaneous separation and determination of palonosetron hydrochloride and four process impurities A-D (including a degradation product). The column used in the method employs octadecyl silane bonded silica gel as a filler, and the method employs an inorganic salt buffer system supplemented with a certain proportion of an ion pair reagent and an organic solvent as the mobile phases for gradient elution. The method can simultaneously fully separate the process impurities and degradation products of palonosetron hydrochloride, has the advanategs of simpleness, feasibility, good reproducibility and strong specificity, and can effectively determinw palonosetron hydrochloride bulk drugs and medicine and the content of the relevant materials in the preparation.

Description

technical field [0001] The invention belongs to the field of analytical chemistry, and in particular relates to a method for separating and measuring palonosetron hydrochloride and four impurities thereof (including a degradation product) by using high-performance liquid chromatography. Background technique [0002] Palonosetron Hydrochloride (Palonosetron Hydrochloride) was synthesized in 1991 by Berger, J et al. It was successfully developed by Helsinn Healthcare in Switzerland, and MGI Pharma purchased the right to sell the drug in North America. It was approved by the FDA in 2003 and launched in the United States in September of the same year. For the prophylaxis of acute or delayed nausea and vomiting induced by moderately or highly emetogenic chemotherapy. This product is highly selective 5-HT 3 Receptor antagonist, the effect is obvious. Palonosetron hydrochloride chemical name 2-[1-azabicyclo(2.2.2)oct-3S-yl]-2,3,3aS,4,5,6-hexahydro-1H-benzo[de] Isoquinolin-1-one...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): G01N30/88
Inventor 林晓兵张波
Owner CHONGQING HUAPONT PHARMA
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