Detection method for flupenthixol and melitracen compound drug impurities, new identifiable impurities and safer compound drug

A flupentixol and detection method technology, which can be used in measurement devices, pharmaceutical formulations, medical preparations containing active ingredients, etc., and can solve problems such as unclear source attribution and unknown impurity control amount

Active Publication Date: 2018-08-03
CHENGDU BRILLIANT PHARMA CO LTD
View PDF2 Cites 11 Cited by
  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0008] In the inventor's further research, it was found that in addition to the above-mentioned impurities, the sources of other unknown impurities in the flupentixol-melitracen compound drug were not clear, which led to the emergence of the controlled amount of these unknown impurities. question

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
  • Detection method for flupenthixol and melitracen compound drug impurities, new identifiable impurities and safer compound drug
  • Detection method for flupenthixol and melitracen compound drug impurities, new identifiable impurities and safer compound drug
  • Detection method for flupenthixol and melitracen compound drug impurities, new identifiable impurities and safer compound drug

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0081] Verification of impurities:

[0082] Take blank excipients, flupenthixol hydrochloride, melitracen hydrochloride, flupentixol hydrochloride plus blank excipients, melitracen hydrochloride plus blank excipients, flupentixol hydrochloride plus melitracen hydrochloride, flupenthixine hydrochloride Tonmelitracen Capsules (hereinafter referred to as the test product) was subjected to drug degradation test; and the degraded sample was analyzed by high performance liquid chromatography, and its chromatogram was recorded; other spectra except the test product were superimposed , and compared with the spectrum measured by the test product, as attached figure 1 Shown, by comparing the same retention time chromatographic peak and its full spectrum in different solution chromatograms, it can be seen that in the test sample, impurities are derived from flupenthixol except known impurity G, impurity Lu-28-159, There are also 6 unknown impurities, which are consistent with the substa...

Embodiment 2

[0085] Detect and calculate the impurities and their content in flupentixol melitracen compound drug according to the following process:

[0086] (1) Take the standard reference substances of impurity A and impurity G, accurately weigh them, dilute and dissolve with methanol to constant volume, and make impurity stock solutions containing about 0.2 mg of impurity A and 0.1 mg of impurity G in every 1 mL of the mixed solution;

[0087] (2) Take flupentixol hydrochloride standard reference substance, melitracen hydrochloride standard reference substance, impurity Lu-28-159 standard reference substance (during actual operation, use the salt Lu 28-159-HCl of impurity Lu-28-159 For the injection object), accurately weighed and dissolved with an appropriate amount of diluent, the diluent includes mobile phase A solution and methanol with a concentration of 0.01mol / L, and the volume ratio of the two is 35:65 to obtain the second stock solution;

[0088] (3) Measure the impurity stock...

Embodiment 3

[0145] Embodiment 3, comparative example

[0146] Detect and calculate the impurities and their content in flupentixol melitracen compound drug according to the following process:

[0147] (1) Take the standard reference substances of impurity A and impurity G, accurately weigh them, dilute and dissolve with methanol to constant volume, and make impurity stock solutions containing about 0.2 mg of impurity A and 0.1 mg of impurity G in every 1 mL of the mixed solution;

[0148] (2) Take flupentixol hydrochloride standard reference substance, melitracen hydrochloride standard reference substance, impurity Lu-28-159 standard reference substance (during actual operation, use the salt Lu 28-159-HCl of impurity Lu-28-159 For the injection object), accurately weighed and dissolved with an appropriate amount of diluent, the diluent includes mobile phase A solution and methanol with a concentration of 0.01mol / L, and the volume ratio of the two is 35:65 to obtain the second stock soluti...

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 discloses a detection method for flupenthixol and melitracen compound drug impurities, new identifiable impurities and a safer compound drug, wherein the detection method comprises the process of carrying out gradient elution in a high performance liquid chromatographic column containing an octadecyl silane bonded silica gel filler in 0-60 min and analyzing a spectrogram furthermore.The detection method can identify various impurities of the flupenthixol and melitracen compound drug and the accurate contents of the impurities, and specially can separate and identify 6 new oxidative and degradable impurities, and thus safer drug control standards for the flupenthixol and melitracen compound drug are obtained.

Description

technical field [0001] The invention relates to the technical field of flupentixol and melitracen compound medicine. Background technique [0002] Common dosage forms of flupenthixol and melitracen compound drugs, such as flupenthixol and melitracen tablets, flupenthixol and melitracen capsules, etc., all contain two drugs, flupentixol and melitracen, And there is a huge difference in the labeled amounts of the two. For example, each flupentixol and melitracen capsule contains 0.5 mg of flupentixol and 10 mg of melitracen, and the difference in the labeled amounts of the two reaches 20 times. Reasonable, scientific and strict quality control of drug quality is particularly important. [0003] In the existing standards, the impurities of flupenthixol and melitracen compound drug mainly include the degradation impurity Lu-28-159 and impurity G from flupentixol, in addition to the process impurity F, from the degradation of melitracen Impurity impurity A (Lu 23-120), its resp...

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
Patent Type & Authority Applications(China)
IPC IPC(8): G01N30/02A61K31/496A61K31/382A61K31/122
CPCA61K31/122A61K31/382A61K31/496G01N30/02A61K2300/00
Inventor 陈礼莉胡崇琳徐成福刘丽娟李英富苏忠海
Owner CHENGDU BRILLIANT PHARMA CO LTD
Who we serve
  • R&D Engineer
  • R&D Manager
  • IP Professional
Why Eureka
  • Industry Leading Data Capabilities
  • Powerful AI technology
  • Patent DNA Extraction
Social media
Try Eureka
PatSnap group products

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

© 2024 PatSnap. All rights reserved.Legal|Privacy policy|Modern Slavery Act Transparency Statement|Sitemap