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Sci. Pharm. 2011, 79(4), 865-876; doi:10.3797/scipharm.1106-23

A Sensitive and Simple HPLC-UV Method for Trace Level Quantification of Ethyl p-Toluenesulfonate and Methyl p-Toluenesulfonate, Two Potential Genotoxins in Active Pharmaceutical Ingredients

1
Center of Pharmaceutical Sciences, IST, Jawaharlal Nehru Technological University, 500072, Kukatpally, Hyderabad, India
2
Aptuit Laurus Private Limited, ICICI knowledge park, 500078, Turkapally, Hyderabad, India
*
Author to whom correspondence should be addressed.
Received: 27 June 2011 / Accepted: 20 September 2011 / Published: 20 September 2011
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Abstract

A sensitive and simple HPLC/UV method has been developed and validated for the determination of two potential genotoxic impurities, namely methyl p-toluenesulfonate (MPTS) and ethyl p-toluenesulfonate (EPTS) at trace levels in Pemetrexed sodium API. Applying the concept of threshold of toxicological concern (TTC), a limit of 3 ppm each for both genotoxins was calculated based on the maximum daily dose of API. A reversed phase LC method using UV detection was developed and validated. The method was found to be specific and selective for the application. The limit of detection (LOD) and limit of quantitation (LOQ) for both MPTS and EPTS was found to be 0.15 ppm (0.009 μg mL−1) and 0.5 ppm (0.03 μg mL−1), respectively, with respect to sample concentration. The calibration curves of MPTS and EPTS were linear over the concentration range from LOQ to 6 μg/mL. The method was found to be specific, precise, linear and accurate and has been successfully applied to determine the two genotoxins in commercial batches of the API.
Keywords: Threshold of toxicological concern; Genotoxin; Daily dosage; Active Pharmaceutical Ingredient; Validation Threshold of toxicological concern; Genotoxin; Daily dosage; Active Pharmaceutical Ingredient; Validation
This is an open access article distributed under the Creative Commons Attribution License which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited. (CC BY 4.0).

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MDPI and ACS Style

NAGESWARI, A.; VENKATA SIVA RAMA KRISHNA REDDY, K.; MUKKANTI, K. A Sensitive and Simple HPLC-UV Method for Trace Level Quantification of Ethyl p-Toluenesulfonate and Methyl p-Toluenesulfonate, Two Potential Genotoxins in Active Pharmaceutical Ingredients. Sci. Pharm. 2011, 79, 865-876.

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