Detection method for meclozine hydrochloride tablet-related substances

A technology of meclizine hydrochloride tablets and meclizine hydrochloride, which can be used in measurement devices, instruments, scientific instruments, etc., can solve the problems of chromatographic column damage, large mobile phase, large concentration, etc.

Active Publication Date: 2012-11-14
BEIJING YILING BIOENG
View PDF2 Cites 0 Cited by
  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

This species is recorded in the 32nd edition of the United States Pharmacopoeia. There are two main problems in the detection method of related substances in preparations: 1. When the mobile phase ratio changes slightly, the retention time of the active ing

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 meclozine hydrochloride tablet-related substances
  • Detection method for meclozine hydrochloride tablet-related substances
  • Detection method for meclozine hydrochloride tablet-related substances

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0097] The chromatographic conditions are: the chromatographic column is Kromasil 100-5 phenyl chromatographic column, the specification is 250 mm×4.6 mm, 5 μm; the mobile phase: A is methanol, B is diammonium hydrogen phosphate solution with pH 7.0; the gradient elution program is 0→5.0min, A is 80%; 5.0→35.0min, A changes from 80% to 95%; 35.0→35.01min, A changes from 95% to 80%; 35.01→45.0min, A is 80%; flow rate 1.0 ml / min; detection wavelength: 225 nm; column temperature: 30°C; theoretical plate number based on meclizine hydrochloride should not be less than 2000;

[0098] Determination method: 10 tablets of this product, grind finely, take the powder equivalent to 50mg of meclizine hydrochloride, accurately weigh it, put it in a 50ml volumetric flask, use the mixed solution of mobile phase A and B as the diluent, wherein A is 80% , dissolve with a diluent and dilute to the mark, shake well, filter, and take the subsequent filtrate as the test solution; accurately weigh t...

Embodiment 2

[0102] The chromatographic conditions are: the chromatographic column is a Crest Phenyl phenyl column, the specification is 250mm×4.6 mm, 5 μm; the mobile phase: A is methanol, B is diammonium hydrogen phosphate solution with pH 7.0; the gradient elution program is 0→5.0 min, A is 80%; 5.0→35.0min, A changes from 80% to 95%; 35.0→35.01min, A changes from 95% to 80%; 35.01→45.0min, A is 80%; flow rate 1.0ml / min ; Detection wavelength: 225 nm; Column temperature is 30°C; The number of theoretical plates should not be less than 2000 based on meclizine hydrochloride;

[0103] Determination method: 10 tablets of this product, grind finely, take the powder equivalent to 50mg of meclizine hydrochloride, accurately weigh it, put it in a 50ml volumetric flask, use the mixed solution of mobile phase A and B as the diluent, wherein A is 60% , dissolve with a diluent and dilute to the mark, shake well, filter, and take the subsequent filtrate as the test solution; accurately weigh the mec...

Embodiment 3

[0107] The chromatographic conditions are: the chromatographic column is a YMC-Pack phenyl chromatographic column, the specification is 250 mm×4.6 mm, 5 μm; the mobile phase: A is methanol, B is diammonium hydrogen phosphate solution with pH 7.0; the gradient elution program is 0→5.0min, A is 80%; 5.0→35.0min, A changes from 80% to 95%; 35.0→35.01min, A changes from 95% to 80%; 35.01→45.0min, A is 80%; flow rate 1.0 ml / min; detection wavelength: 225 nm; column temperature: 30°C; theoretical plate number based on meclizine hydrochloride should not be less than 2000;

[0108] Determination method: 10 tablets of this product, grind finely, take the powder equivalent to 50mg of meclizine hydrochloride, accurately weigh it, put it in a 50ml volumetric flask, use the mixed solution of mobile phase A and B as the diluent, wherein A is 90% , dissolve with a diluent and dilute to the mark, shake well, filter, and take the subsequent filtrate as the test solution; accurately weigh the m...

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 an analytical method for stability and indicativity of meclozine hydrochloride tablet-related substances. Meclozine hydrochloride is a first generation of piperazine antihistaminic agent, is suitable for preventing and treating nausea, vomit and dizziness caused by motion sickness, and is effective for megrim caused by vestibular diseases. The method employs high performance liquid chromatography to detect meclozine hydrochloride tablet-related substances, and can be used for quality control of meclozine hydrochloride tablets.

Description

technical field [0001] The invention relates to a method for determining related substances of meclizine hydrochloride tablets, which belongs to the technical field of drug analysis. Background technique [0002] Related substance inspection is an important indicator of drug quality control. It is especially important to establish a test method for the accurate determination of impurities. Strict control of related substances is inseparable from analytical methods with strong specificity and high sensitivity, and the screening and verification of analytical methods. Meclazine hydrochloride tablets are included in the 32nd edition of the United States Pharmacopoeia. This species is recorded in the 32nd edition of the United States Pharmacopoeia. There are two main problems in the detection method of related substances in preparations: 1. When the mobile phase ratio changes slightly, the retention time of the active ingredient changes relatively; 2. The flow rate is set in th...

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
Inventor 张梅华郝褔马静杨超
Owner BEIJING YILING BIOENG
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