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Development and Validation of a Stability-Indicating RP-HPLC Method for the Simultaneous Estimation of Guaifenesin and Dextromethorphan Impurities in Pharmaceutical Formulations
Joint Authors
Mrutyunjaya Rao, Ivaturi
Raja Kumar, Seshadri
Malleswara Reddy, Annarapu
Someswara Rao, Nittala
Anil Kumar, Noru
Raghava Raju, Thummala V.
Source
Chromatography Research International
Issue
Vol. 2013, Issue 2013 (31 Dec. 2013), pp.1-12, 12 p.
Publisher
Hindawi Publishing Corporation
Publication Date
2013-09-23
Country of Publication
Egypt
No. of Pages
12
Main Subjects
Abstract EN
A sensitive, stability-indicating gradient RP-HPLC method has been developed for the simultaneous estimation of impurities of Guaifenesin and Dextromethorphan in pharmaceutical formulations.
Efficient chromatographic separation was achieved on a Sunfire C18, 250 × 4.6 mm, 5 µm column with mobile phase containing a gradient mixture of solvents A and B.
The flow rate of the mobile phase was 0.8 mL min−1 with column temperature of 50°C and detection wavelength at 224 nm.
Regression analysis showed an r value (correlation coefficient) greater than 0.999 for Guaifenesin, Dextromethorphan, and their impurities.
Guaifenesin and Dextromethorphan formulation sample was subjected to the stress conditions of oxidative, acid, base, hydrolytic, thermal, and photolytic degradation.
Guaifenesin was found stable and Dextromethorphan was found to degrade significantly in peroxide stress condition.
The degradation products were well resolved from Guaifenesin, Dextromethorphan, and their impurities.
The peak purity test results confirmed that the Guaifenesin and Dextromethorphan peak was homogenous and pure in all stress samples and the mass balance was found to be more than 98%, thus proving the stability-indicating power of the method.
The developed method was validated according to ICH guidelines with respect to specificity, linearity, limits of detection and quantification, accuracy, precision, and robustness.
American Psychological Association (APA)
Raghava Raju, Thummala V.& Anil Kumar, Noru& Raja Kumar, Seshadri& Malleswara Reddy, Annarapu& Someswara Rao, Nittala& Mrutyunjaya Rao, Ivaturi. 2013. Development and Validation of a Stability-Indicating RP-HPLC Method for the Simultaneous Estimation of Guaifenesin and Dextromethorphan Impurities in Pharmaceutical Formulations. Chromatography Research International،Vol. 2013, no. 2013, pp.1-12.
https://search.emarefa.net/detail/BIM-462793
Modern Language Association (MLA)
Raghava Raju, Thummala V.…[et al.]. Development and Validation of a Stability-Indicating RP-HPLC Method for the Simultaneous Estimation of Guaifenesin and Dextromethorphan Impurities in Pharmaceutical Formulations. Chromatography Research International No. 2013 (2013), pp.1-12.
https://search.emarefa.net/detail/BIM-462793
American Medical Association (AMA)
Raghava Raju, Thummala V.& Anil Kumar, Noru& Raja Kumar, Seshadri& Malleswara Reddy, Annarapu& Someswara Rao, Nittala& Mrutyunjaya Rao, Ivaturi. Development and Validation of a Stability-Indicating RP-HPLC Method for the Simultaneous Estimation of Guaifenesin and Dextromethorphan Impurities in Pharmaceutical Formulations. Chromatography Research International. 2013. Vol. 2013, no. 2013, pp.1-12.
https://search.emarefa.net/detail/BIM-462793
Data Type
Journal Articles
Language
English
Notes
Includes bibliographical references
Record ID
BIM-462793