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Genotoxic impurity method development and validation by GCMS for the analysis of methyl methane sulfonate (MMS) in Zidovudine drug substance

Nalavade Atul Kakasaheb, K.Ramakrishna, V.Srinivasarao

Zidovudine is chemically known as 1-(3-Azido-2, 3-dideoxy-beta-Dribofuranosyl) thymine and is the first approved treatment for HIV and is included in world health organization essential drug list. Zidovudine that is also termed as azidothymidine (AZA), is a nucleoside analog reverse transcriptor inhibitor (NRTI) and is a kind of antiretroviral drug for the treatment of human immunodeficiency virus infection / acquired immunodeficiency syndrome (HIV/AIDS). Methyl methanesulfonate is a know genotoxic impurity and is potential process impurity of zidovudine. The method development and subsequent validation activity was done for the analysis of methyl methanesulfonate (MMS) in zidovudine drug substance. The development activity was conducted by gas chromatography technique with mass spectrometer as detector. Capillary column used in the method was Rtx-1301, with length 60 meter, internal diameter 0.25mm, filmthickness 0.25 µm with helium as carrier gas. Validation of the method is conducted based on international conference on harmonization (ICH) guidelines. The LOD and LOQ values are found to be 0.04 and 0.12 µg/g (i.e. 0.004 and 0.012 µg/mL) respectively for MMS.