Looking for breakthrough ideas for innovation challenges? Try Patsnap Eureka!

Method for detecting related substances of palonosetron hydrochloride injection

A technology of palonosetron and detection method is applied in the field of detection of related substances in palonosetron hydrochloride injection, can solve problems such as short time consumption, and achieve the effects of short time consumption, accurate results and high sensitivity

Pending Publication Date: 2019-08-20
JIANGSU AOSAIKANG PHARMA CO LTD
View PDF3 Cites 1 Cited by
  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Therefore, there is currently no report on a method that can completely separate the relevant impurities of palonosetron hydrochloride injection at the same time, so a one-time separation is developed, which takes less time, requires less organic solvent, and is reproducible and durable. A better method becomes necessary

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 more

Image

Smart Image Click on the blue labels to locate them in the text.
Viewing Examples
Smart Image
  • Method for detecting related substances of palonosetron hydrochloride injection
  • Method for detecting related substances of palonosetron hydrochloride injection
  • Method for detecting related substances of palonosetron hydrochloride injection

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0056] This embodiment adopts the following specific steps:

[0057] (1) SPE cartridge pretreatment: add 3mL of solvent I (acetonitrile) to the cartridge, then add 3mL of water to the cartridge for cleaning, and control the flow rate to 1.5mL / min.

[0058] (2) Palonosetron hydrochloride injection pretreatment: to the solution to be tested according to the limit concentration (the mass percentage of impurity A and impurity B is 0.1%, the mass percentage of impurity C, D, E and enantiomer The percentage content is 0.5%) After adding impurities A, B, C, D, E and enantiomers, adjust the pH to 11.0 with 1mol / L NaOH as the test solution.

[0059] (3) Palonosetron Hydrochloride Injection was enriched by solid-phase extraction cartridges: 15 mL of the test solution was precisely pipetted and added to the cartridges at a flow rate of 1.5 mL / min.

[0060] (4) Pretreatment of solid-phase extraction column elution: after the solid-phase extraction column enriches the test product, accura...

Embodiment 2

[0066] According to the detection method of Example 1, wherein the pH of the test solution is adjusted to 10.5. The recoveries of various impurities and enantiomers are in the range of 90.0% to 110%, indicating that the determination method of the present invention has high accuracy.

Embodiment 3

[0068] According to the detection method of Example 1, wherein the pH of the test solution is adjusted to 12.0. The recoveries of various impurities and enantiomers are in the range of 90.0% to 110%, indicating that the determination method of the present invention has high accuracy.

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

No PUM Login to View More

Abstract

The invention provides a method for detecting related substances of palonosetron hydrochloride injection, which comprises the steps of enriching the palonosetron hydrochloride injection by adopting asolid phase extraction cartridge, eluting, and performing liquid chromatography analysis under the conditions that: chromatographic column: the filler is bonded vancomycin; detection wavelength: 235 to 245 nm; column temperature: 30-40 DEG C; flow rate: 1.4-1.6 mL / min; mobile phase: ammonium acetate solution and tetrahydrofuran mixed solution. The related substances of the palonosetron hydrochloride enriched by the method can be concentrated by more than 10 times, the influence of auxiliary materials can be removed at the same time, one-time extraction and detection of fat-soluble and water-soluble impurities in a sample can be realized, the related substances can be accurately detected, therefore, the method is high in sensitivity, simple and convenient to operate and accurate in result.

Description

technical field [0001] The invention relates to the field of analytical chemistry, in particular to a method for detecting related substances in palonosetron hydrochloride injection. Background technique [0002] Palonosetron hydrochloride is a 5-HT3 receptor selective antagonist antiemetic with strong affinity, which is used to prevent acute nausea and vomiting (CINV) caused by highly emetogenic chemotherapy and to prevent nausea caused by moderately emetogenic chemotherapy ,Vomit. It is the first and currently only approved 5-HT3 receptor antagonist available. The clinical guidelines of the American Comprehensive Cancer Network have recommended palonosetron hydrochloride injection as the drug of choice. The chemical name of palonosetron hydrochloride is: 2-[1-azabicyclo(2.2.2)oct-3S-yl]-2,3,3aS,4,5,6-hexahydro-1H-benzo[ de] isoquinolin-1-one hydrochloride, its structural formula is: [0003] [0004] The molecular formula is: C 19 h 24 N 2 O.HCl, molecular weight...

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
no application Login to View More
IPC IPC(8): G01N30/02
CPCG01N30/02
Inventor 陈祥峰陈虹宇杜有国陈飞强孙平
Owner JIANGSU AOSAIKANG PHARMA CO LTD
Who we serve
  • R&D Engineer
  • R&D Manager
  • IP Professional
Why Patsnap Eureka
  • Industry Leading Data Capabilities
  • Powerful AI technology
  • Patent DNA Extraction
Social media
Patsnap Eureka Blog
Learn More
PatSnap group products

Browse by: Latest US Patents, China's latest patents, Technical Efficacy Thesaurus, Application Domain, Technology Topic, Popular Technical Reports.

© 2024 PatSnap. All rights reserved.Legal|Privacy policy|Modern Slavery Act Transparency Statement|Sitemap|About US| Contact US: help@patsnap.com