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
Joint Authors
Rao, K. Lakshmi Narasimha
Krishnaiah, Ch.
Babu, K. Sudheer
Reddy, K. Padmaja
Source
Journal of Saudi Chemical Society
Issue
Vol. 18, Issue 5 (31 Dec. 2014), pp.593-600, 8 p.
Publisher
Publication Date
2014-12-31
Country of Publication
Saudi Arabia
No. of Pages
8
Main Subjects
Pharmacy, Health & Medical Sciences
Abstract EN
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 1.0 mL min 1 and quantitation was carried out using ultraviolet detection at 222 nm 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 1.5 mg mL 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).
American Psychological Association (APA)
Rao, K. Lakshmi Narasimha& Krishnaiah, Ch.& Babu, K. Sudheer& Reddy, K. Padmaja. 2014. 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. Journal of Saudi Chemical Society،Vol. 18, no. 5, pp.593-600.
https://search.emarefa.net/detail/BIM-413976
Modern Language Association (MLA)
Rao, K. Lakshmi Narasimha…[et al.]. 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. Journal of Saudi Chemical Society Vol. 18, no. 5 (2014), pp.593-600.
https://search.emarefa.net/detail/BIM-413976
American Medical Association (AMA)
Rao, K. Lakshmi Narasimha& Krishnaiah, Ch.& Babu, K. Sudheer& Reddy, K. Padmaja. 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. Journal of Saudi Chemical Society. 2014. Vol. 18, no. 5, pp.593-600.
https://search.emarefa.net/detail/BIM-413976
Data Type
Journal Articles
Language
English
Notes
Includes bibliographical references : p. 600
Record ID
BIM-413976