International Journal of Science and Research (IJSR)

International Journal of Science and Research (IJSR)
www.ijsr.net | Most Trusted Research Journal Since Year 2012

ISSN: 2319-7064

Research Paper | Chemistry Science | India | Volume 2 Issue 12, December 2013

Quantification of Genotoxic Alkylating Impurity Butyl3-Methyl-3-(6-methoxy-2-naphtyl) Glycidate at ppm Level by LCMS/MS in Naproxen Drug Substance

Narayana MBV, Chandrasekhar KB, Rao BM

The objective of present research work is to develop a suitable LCMS/MS method for the quantitative determination of suspected genotoxic impurity namely Sec. Butyl 3-methyl-3- (6-methoxy-2-naphtyl) glycidate present in Naproxen drug substance at ppm level. The LCMS/MS method was developed on Luna C18, 50 mm column using the mobile phase consists a mixture of 10 mM Ammoinium acetate and Acetonirile with isocratic composition of 10: 90 at a flow rate of 0.8 mL/min respectively. Ion source is electospray ionization (ESI) positive mode, source temperature is 350C, gas flow is 10 L/min, Nebuliser pressure is 50 psi, and capillary voltage is 4000 V. Under these LC and MS conditions Sec. Butyl 3-methyl-3- (6-methoxy-2-naphtyl) glycidate was quantified by selecting most stable MRM pair m/z of 315/213. 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 impurity at ppm level. Validation of the developed LCMS/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 LCMS/MS method was found to be suitable to quantify the genotoxic impurity at ppm level present in Naproxen drug substance.

Keywords: Genotoxic impurity, Alkylating agent, Liquid chromatography mass spectrometer, Electro spray ionization

Edition: Volume 2 Issue 12, December 2013

Pages: 319 - 323


How to Cite this Article?

Narayana MBV, Chandrasekhar KB, Rao BM, "Quantification of Genotoxic Alkylating Impurity Butyl3-Methyl-3-(6-methoxy-2-naphtyl) Glycidate at ppm Level by LCMS/MS in Naproxen Drug Substance", International Journal of Science and Research (IJSR), https://www.ijsr.net/search_index_results_paperid.php?id=02013646, Volume 2 Issue 12, December 2013, 319 - 323

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Research Paper, Chemistry Science, India, Volume 2 Issue 12, December 2013

Pages: 319 - 323

Quantification of Genotoxic Alkylating Impurity Butyl3-Methyl-3-(6-methoxy-2-naphtyl) Glycidate at ppm Level by LCMS/MS in Naproxen Drug Substance

Narayana MBV, Chandrasekhar KB, Rao BM

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