Document Detail


Development and validation of a specific stability indicating high performance liquid chromatographic method for rizatriptan benzoate.
MedLine Citation:
PMID:  16563688     Owner:  NLM     Status:  MEDLINE    
Abstract/OtherAbstract:
A gradient, reversed-phase liquid chromatographic (RP-LC) method was developed for the quantitative determination of rizatriptan benzoate, used to treat relieves migraine headache symptoms. The developed method can be also employed for the related substance determination in bulk samples. Forced degradation studies were performed on bulk sample of rizatriptan benzoate using acid (0.5 N hydrochloric acid), base (0.1 N sodium hydroxide), oxidation (3.0% hydrogen peroxide), water hydrolysis, heat (60 degrees C) and photolytic degradation. Mild degradation of the drug substance was observed in base hydrolysis and considerable degradation observed during oxidative stress. The chromatographic method was fine tuned using the samples generated from forced degradation studies. Good resolution between the peaks corresponds to degradation products and the analyte was achieved on Agilent Zorbax SB-CN (250 mm x 4.6 mm, 5 microm) column. The mobile phase consists of a mixture of aqueous potassium di hydrogen ortho phosphate (pH 3.4), acetonitrile and methanol. The stress sample solutions were assayed against the qualified reference standard of rizatriptan benzoate and the mass balance in each case was close to 99.7% indicating that the developed method is stability indicating. Validation of the developed method was carried out as per ICH requirements.
Authors:
B Mallikarjuna Rao; Sivaiah Sangaraju; M K Srinivasu; P Madhavan; M Lalitha Devi; P Rajendra Kumar; K B Chandrasekhar; Ch Arpitha; T Satya Balaji
Related Documents :
20585908 - Simple chromatographic method for simultaneous analyses of phosphatidylcholine, lysopho...
2258398 - Controlled thermal degradation for the identification and quantification of amine n-oxi...
11853478 - Analysis and detection of the herbicides dimethenamid and flufenacet and their sulfonic...
16667908 - Tracheid production in response to changes in the internal level of indole-3-acetic aci...
11707948 - Migration behavior of alkylphenols, bisphenol a and bisphenol s studied by capillary el...
24954648 - A novel tracer method to measure isotopic labeled gas-phase nitrous acid (ho15no) in bi...
Publication Detail:
Type:  Journal Article     Date:  2006-03-23
Journal Detail:
Title:  Journal of pharmaceutical and biomedical analysis     Volume:  41     ISSN:  0731-7085     ISO Abbreviation:  J Pharm Biomed Anal     Publication Date:  2006 Jun 
Date Detail:
Created Date:  2006-05-30     Completed Date:  2006-08-02     Revised Date:  -    
Medline Journal Info:
Nlm Unique ID:  8309336     Medline TA:  J Pharm Biomed Anal     Country:  England    
Other Details:
Languages:  eng     Pagination:  1146-51     Citation Subset:  IM    
Affiliation:
Analytical Research, Custom Pharmaceutical Services, Dr. Reddy's Laboratories, Hyderabad 500049, India. bmrao@dreddys.com
Export Citation:
APA/MLA Format     Download EndNote     Download BibTex
MeSH Terms
Descriptor/Qualifier:
Chromatography, High Pressure Liquid / methods*
Drug Contamination
Reproducibility of Results
Serotonin Agonists / analysis*
Triazoles / analysis*
Tryptamines / analysis*
Chemical
Reg. No./Substance:
0/Serotonin Agonists; 0/Triazoles; 0/Tryptamines; 145202-66-0/rizatriptan

From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine


Previous Document:  The stability of the amorphous form of cefuroxime axetil in solid state.
Next Document:  Quantitation of geometric isomers of a phosphodiesterase inhibitor in rat and monkey plasma using li...