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Development and quantification of Ethyl-p-toluene sulfonate and Isopropyl-p-toluene sulfonate at genotoxic level in tenofovir disoproxil fumarate by using advanced technique

Nalavade Atul Kakasaheb, B.Sandhyakumari, K.Ramakrishna, V.Srinivasarao

AsensitiveGC-MSmethodwas developed and validated for the content of Ethyl-p-toluene sulfonate and Isopropyl-p-toluene sulfonate in Tenofovir Disoproxil Fumarate byGCMS.RXI-1ms columnwas selectedwith electron impact ionization technique, Quadrupole mass analyzer.Method is sensitive, precise, accurate and linear as per the parameters conducted for the validation activity. Calibration curve showed good linearity over the concentration range LOQ to 150% of the evaluation level. Limit of detection and Limit of Quantification for Ethyl-p-toluene sulfonate is 0.15µg/g (0.006µg/mL) and 0.45µg/g (0.019µg/mL) respectively. Limit of detection and Limit of Quantification for Isopropyl-p-toluene sulfonate is 0.21µg/g (0.008µg/mL) and 0.65µg/g (0.026µg/mL) respectively. Also method is evaluated for accuracy at 50 to 150%of the evaluation limit.