Potential genotoxic impurities used in the synthesis of pharmaceutical substances should be identified based on the existing genotoxicity data or the presence of structural alerts and then determined by suitable analytical techniques. 2-iodopropane,  halogenated aliphatic compound, has been used during the synthesis of Latanoprost and could be recognized as a potential genotoxic impurity.

     The analytical procedure for the determination of residual 2-iodopropane in Latanoprost is described and validated. 2-iodopropane was determined by gas chromatography with the use of flame-ionization detector and DB-624 (60 m long, 0.32 mm ID) column. The program of column temperature was the following: 100ºC, ramp 2ºC/min to 130ºC, ramp 40ºC/min to 240ºC, 10 minutes at final temperature. The developed method allows for the determination of 2-iodopropane in the presence of other solvents arising from the synthesis route of Latanoprost.

     The different validation criteria such as selectivity, specificity, system precision, method precision, intermediate precision, accuracy (recovery), linearity, limits of detection and quantitation (in substance), robustness were considered.

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