Quantification of Genotoxic Impurity 4-Chloro-1-Hydroxy Butane Sulfonic Acid Sodium Salt by LCMS/MS in Sumatriptan Succinate
- *Corresponding Author:
- Narayana MBV
Matrix Laboratories limited
Hyderabad 500 072, India
E-mail: [email protected]
Received Date: November 27, 2012; Accepted Date: December 26, 2012; Published Date: December 31, 2012
Citation: Narayana MBV, Chandrasekhar KB, Rao BM (2012) Quantification of Genotoxic Impurity 4-Chloro-1-Hydroxy Butane Sulfonic Acid Sodium Salt by LCMS/ MS in Sumatriptan Succinate. J Bioanal Biomed 4:104-107. doi:10.4172/1948-593X.1000072
Copyright: © 2012 Narayana MBV, et al. This is an open-access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.
The objective of present research work is to develop a suitable LCMS/MS method for the quantitative
determination of genotoxic impurity 4-Chloro-1-Hydroxy Butane Sulfonic Acid Sodium Salt at ppm level present in Sumariptan dug substance. The LCMS/MS method was developed on Zorbax SB-C8 column using the mobile phase consists a mixture of 0.05% (v/v) Formic acid in water and Acetonirile using a isocratic composition of 90:10 (v/v) at a flow rate of 0.8 mL/min. Ion source is electospray ionization (ESI), source temperature is 325°C, gas flow is 8 L/min, Nebuliser pressure is 40 psi, capillary voltage is 4000 V. Under these conditions impurity was quantified by selecting most stable MRM pair (187/81). The limit of detection and the limit of quantitation for the impurity were established. 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. This method has been tested in a number of Sumatriptan samples and used successfully for quantification of the impurity at ppm level. The developed LCMS/MS method was found to be suitable to quantify the genotoxic impurity 4-Chloro-1-Hydroxy Butane Sulfonic Acid Sodium Salt at ppm level present in Sumatriptan Succinate.