Document Detail


Validation of a sensitive ion chromatography method for determination of monoethylsulfate in Indinavir sulfate drug substance.
MedLine Citation:
PMID:  19616913     Owner:  NLM     Status:  MEDLINE    
Abstract/OtherAbstract:
The present study relates to the optimization of an ion chromatography method to determine the content of monoethylsulfate at very low levels in Indinavir sulfate drug substance, and subsequent validation of the method to prove its suitability, reliability and sensitivity. Monoethylsulfate is a potential impurity of Indinavir sulfate, and may forms during the preparation as well as during storage. The ion chromatography method was developed in such a way that to enhance the detection level by introducing suppressor, and minimizing acquisition time by using suitable buffer of 3.2 mmole of sodium carbonate and 1 mmole of sodium hydrogen carbonate in water as eluent. The retention time of monoethylsulfate was about 9.5 min and the total acquisition time was 25 min. The optimized method was validated to prove its performance characteristics by demonstrating selectivity, sensitivity (limit of detection and quantification), linearity, precision and accuracy. The established limit of detection and quantification of monoethylsulfate in Indinavir sulfate by this method was found to be 24 ng/ml and 74 ng/ml respectively, and the overall percent accuracy (recovery) of samples evaluated at different concentration levels was found to be 97.1, indicating the sensitivity and accuracy of this optimized ion chromatography method.
Authors:
S John Prasanna; Hemant Kumar Sharma; K Mukkanti; M Sivakumaran; K S R Pavan Kumar; V Jagadeesh Kumar
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Publication Detail:
Type:  Journal Article     Date:  2009-06-27
Journal Detail:
Title:  Journal of pharmaceutical and biomedical analysis     Volume:  50     ISSN:  1873-264X     ISO Abbreviation:  J Pharm Biomed Anal     Publication Date:  2009 Dec 
Date Detail:
Created Date:  2009-09-25     Completed Date:  2010-01-12     Revised Date:  -    
Medline Journal Info:
Nlm Unique ID:  8309336     Medline TA:  J Pharm Biomed Anal     Country:  England    
Other Details:
Languages:  eng     Pagination:  1065-9     Citation Subset:  IM    
Affiliation:
Aurobindo Pharma Limited, Research Centre, 313, Bachupally, Qutubullapur Mandal, Hyderabad 500 090, India.
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MeSH Terms
Descriptor/Qualifier:
Calibration
Carbonates / analysis
Chemistry, Pharmaceutical / methods
Chromatography / methods*
Dose-Response Relationship, Drug
Electrophoresis, Capillary / methods
Indinavir / analysis*
Models, Chemical
Models, Statistical
Reproducibility of Results
Spectrophotometry, Ultraviolet / methods
Sulfates / analysis*
Temperature
Water / chemistry
Chemical
Reg. No./Substance:
0/Carbonates; 0/Sulfates; 150378-17-9/Indinavir; 497-19-8/sodium carbonate; 7732-18-5/Water

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


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