Development and validation of a stability-indicating LC method for simultaneous determination of related compounds of guaifenesin, terbutaline sulfate and ambroxol HCl in cough syrup formulation

A new liquid chromatographic method has been developed and validated for the determination of terbutaline sulfate (TLS), guaifenesin (GFN) and ambroxol HCl (AML), for its potential impurities in drug substances and drug products. Efficient chromatographic separation was achieved on X-Terra RP-18 col...

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Bibliographic Details
Published inJournal of Saudi Chemical Society Vol. 18; no. 5; pp. 593 - 600
Main Authors Lakshmi Narasimha Rao, K., Krishnaiah, Ch, Sudheer Babu, K., Padmaja Reddy, K.
Format Journal Article
LanguageEnglish
Published Riyadh, Saudi Arabia Elsevier B.V 01.11.2014
Saudi Chemical Society
Subjects
Ambroxol HCl
Analysis
Development and validation
Drug stability
Guaifenesin
High performance liquid chromatography
HPLC
Impurities
Stability indicating
Syrup formulations
Terbutaline sulfate
Impurities
Development and validation
Stability indicating
Guaifenesin
Ambroxol HCl
Syrup formulations
Terbutaline sulfate
HPLC
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Summary:A new liquid chromatographic method has been developed and validated for the determination of terbutaline sulfate (TLS), guaifenesin (GFN) and ambroxol HCl (AML), for its potential impurities in drug substances and drug products. Efficient chromatographic separation was achieved on X-Terra RP-18 column with a simple mobile phase combination containing a gradient mixture of solvents A and B at a flow rate of 1.0mLmin−1 and quantitation was carried out using ultraviolet detection at 222nm with column temperature of 35°C. The resolution between TLS, GFN and AML, its associated impurities was found to be greater than 1.5. Regression analysis shows an r value (correlation coefficient) greater than 0.998. This method was capable to detect all the process impurities of TLS, GFN and AML, at a level below 0.015% with respect to a test concentration of 0.125, 5.0 and 1.5mgmL−1, respectively. The % RSD for the inter-day and intra-day precisions for all the impurities of TLS, GFN and AML were found to be less than 3.0. The method has shown good, consistent recoveries. The drugs were subjected to stress conditions of acid, base, water hydrolysis, oxidation, photolysis and thermal degradation, as prescribed by international conference on harmonization (ICH).
ISSN:1319-6103
DOI:10.1016/j.jscs.2012.01.006