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Quantification of Genotoxic Impurity 2-Butyl p-toluene- sulfonate at ppm Level by LC-MS/MS in Naproxen Drug Substance |
| DUBLIN | CORE | METADATA ITEM | METADATA FOR THIS DOCUMENT |
| 1 | Title | Title of Document | Quantification of Genotoxic Impurity 2-Butyl p-toluene- sulfonate at ppm Level by LC-MS/MS in Naproxen Drug Substance |
| 2 | Creator | Author's name, affiliation, country | M. B. V. NARAYANA1*, K. B.CHANDRASEKHAR2 and B. M. RAO3
11Analytical Research, Matrix Laboratories Limited, Hyderabad-500 072, India
22Department of Chemistry, Jawaharlal Nehru Technological University College of Engineering, Anantapur-515002, India
33Analytical Research, Johnson and Johnson Ltd., Mumbai-400080, India |
| 3 | Subject | Dicipline(s) | Chemical Science |
| 3 | Subject | Keywords | Genotoxic impurity, Alkylating agent, LCMS, Electro spray ionization, Atmospheric chemical ionization |
| 4 | Description | Abstract | The objective of the present research work is to develop a suitable LC-MS/MS method for the quantitative determination of genotoxic alkylating impurity 2-butyl p-toluenesulfonate present in naproxen drug substance at ppm level. The LC-MS/MS method was developed on Xterra MS C18 50 mm column using the mobile phase consists a mixture of 10 mM ammonium acetate and acetonirile using a isocratic composition of 20:80 v/v. Ion source is electrospray ionization (ESI) positive mode, source temperature is 300 oC, gas flow is 10 L/min, Nebuliser pressure is 50 psi, capillary voltage is 4000 V. Under these LC and MS conditions 2-butyl p-toluenesulfonate was quantified by selected ion mode (SIM) of 173. The limit of detection and the limit of quantitation for the impurity were established. This method has been tested in a number of naproxen samples and used successfully for quantification of the genotoxic impurity at ppm level. Validation of the developed LC-MS/MS method was carried out as per ICH requirements and the data shows that the proposed method is specific, linear, accurate, precise and robust. The developed LC-MS/MS method was found to be suitable to quantify the genotoxic impurity at ppm level present in naproxen drug substance. |
| 5 | Publishers | Organizing agency, location | WWW Publications, India |
| 6 | Contributor | Sponsor(s) | - |
| 7 | Date | Date (YYYY-MM-DD) | - |
| 8 | Type | Status & genre | Peer-reviewed Article |
| 8 | Type | Type | |
| 9 | Formate | File Formate | PDF |
| 10 | Identifier | Uniform Resource Identifier | Click Here |
| 10 | Identifier | Digital Object Identifier | |
| 11 | Source | Journal/conference title; vol., no. (Year) | Chemical Science Transactions, Volume 3 , Number (3), (2014) |
| 12 | Lanuguage | English=en | en |
| 13 | Relation | Supp.files | |
| 14 | Coverage | | - |
| 15 | Copyright | Copyright and permissions | |
Chemical Science Transactions | Chem Sci Trans | CST | Online Chemistry Journal | Open Access
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