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Spectrophotometric Methods for Quantitative Determination of Chlorhexidine Gluconate and its Major Impurity, Metabolite and Degradation Product: Para-chloro-aniline

Spectrophotometric Methods for Quantitative Determination of Chlorhexidine Gluconate and its... AbstractFour simple, specific, accurate and precise spectrophotometric methods are developed for determination of chlorhexidine gluconate (CG) in presence of its impurity and/or degradation product namely; para-chloro-aniline (PCA). Method A is derivative spectrophotometry, where CG is determined by first derivative D1 spectrophotometric method in presence of its degradation product PCA at 272 nm, while PCA is determined in presence of CG by second derivative D2 spectrophotometric method at 248.6 nm. Method B is first derivative of ratio spectra spectrophotometry which allows determination of both CG at 266.8 nm and PCA at 328 nm without interference of each other. Method C is dual wavelength spectrophotometry (DWS), where two wavelengths; 233 and 253 nm for CG and 253.8 and 262 nm for PCA are selected for each component in such a way that the difference in absorbance is zero for the second one. Method D is ratio subtraction and extended ratio subtraction spectrophotometry (EXRS), where CG can be determined by dividing the spectrum of the mixture by divisor concentration of 5 μg mL-1 of PCA, while PCA can be determined by dividing the spectrum of the mixture by divisor concentration of 50 μg mL-1 of CG. The specificity of the developed methods is investigated by analyzing different laboratory prepared mixtures of the CG and PCA. Standard deviation values are less than 1.5 in the assay of raw material and tablets. The four methods were statistically compared to the reported method with no significant difference regarding accuracy and precision; assuring their applicability in quality control analysis of drug product. http://www.deepdyve.com/assets/images/DeepDyve-Logo-lg.png Analytical Chemistry Letters Taylor & Francis

Spectrophotometric Methods for Quantitative Determination of Chlorhexidine Gluconate and its Major Impurity, Metabolite and Degradation Product: Para-chloro-aniline

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Spectrophotometric Methods for Quantitative Determination of Chlorhexidine Gluconate and its Major Impurity, Metabolite and Degradation Product: Para-chloro-aniline

Abstract

AbstractFour simple, specific, accurate and precise spectrophotometric methods are developed for determination of chlorhexidine gluconate (CG) in presence of its impurity and/or degradation product namely; para-chloro-aniline (PCA). Method A is derivative spectrophotometry, where CG is determined by first derivative D1 spectrophotometric method in presence of its degradation product PCA at 272 nm, while PCA is determined in presence of CG by second derivative D2 spectrophotometric method at...
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Publisher
Taylor & Francis
Copyright
© 2016 Har Krishan Bhalla & Sons
ISSN
2230-7532
eISSN
2229-7928
DOI
10.1080/22297928.2016.1196148
Publisher site
See Article on Publisher Site

Abstract

AbstractFour simple, specific, accurate and precise spectrophotometric methods are developed for determination of chlorhexidine gluconate (CG) in presence of its impurity and/or degradation product namely; para-chloro-aniline (PCA). Method A is derivative spectrophotometry, where CG is determined by first derivative D1 spectrophotometric method in presence of its degradation product PCA at 272 nm, while PCA is determined in presence of CG by second derivative D2 spectrophotometric method at 248.6 nm. Method B is first derivative of ratio spectra spectrophotometry which allows determination of both CG at 266.8 nm and PCA at 328 nm without interference of each other. Method C is dual wavelength spectrophotometry (DWS), where two wavelengths; 233 and 253 nm for CG and 253.8 and 262 nm for PCA are selected for each component in such a way that the difference in absorbance is zero for the second one. Method D is ratio subtraction and extended ratio subtraction spectrophotometry (EXRS), where CG can be determined by dividing the spectrum of the mixture by divisor concentration of 5 μg mL-1 of PCA, while PCA can be determined by dividing the spectrum of the mixture by divisor concentration of 50 μg mL-1 of CG. The specificity of the developed methods is investigated by analyzing different laboratory prepared mixtures of the CG and PCA. Standard deviation values are less than 1.5 in the assay of raw material and tablets. The four methods were statistically compared to the reported method with no significant difference regarding accuracy and precision; assuring their applicability in quality control analysis of drug product.

Journal

Analytical Chemistry Letters – Taylor & Francis

Published: May 3, 2016

Keywords: Chlorhexidine gluconate; Para-chloro-aniline; Derivative spectrophotometry; First derivative of ratio spectra spectrophotometry; Ratio subtraction; Extended ratio subtraction spectrophotometry

References

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