A rapid, sensitive, specific and accurate UPLC method for determination of Pemetrexed and its impurities in Injectable dosage was developed. A survey of literature revealed that RP-HPLC and UV-visible spectrophotometric methods have been reported for Pemetrexed. The UPLC method for quantification of Pemetrexed is available from Rat plasma.However, there is no reports on Validated UPLC method for determination of Pemetrexed and its impurities in Injectable dosage form. The UPLC system used for

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... thod development and validation was Waters UPLC instrument (Empower 2 software). The determination of Pemetrexed in Injectable dosage form was carried on Acquity UPLC BEH C18 (50 x 2.1 mm, 1.7 µm) column with a mobile phase composed of buffer (0.17% (v/v) Glacial Acetic Acid in water, the pH of the same was adjusted to 5.3 with 50% sodium hydroxide solution) and acetonitrile (89 : 11). The absorbance was measured at 226 nm. The injection volume was 3 µL and flow rate was 0.5 mL/min. The run time for this analysis was 3 minutes. The quantification of impurities of Pemetrexed was carried out on a Waters UPLC instrument (Empower 2 software). There were two impurities (Impurity A & Impurity B) of Pemetrexed which are both process related impurities. The determination of impurities of Pemetrexed in Injectable dosage form was carried on Acquity UPLC BEH C18 (50 x 2.1 mm, 1.7 µm) column with a gradient mobile phase composed of buffer : acetonitrile. The absorbance was measured at 226 nm. The injection volume was 3 µL and flow rate was 0.5 mL/min. The run time for this analysis was 12 minutes. The developed method was validated in terms of linearity, precision, accuracy, robustness, limit of detection, limit of Quantitation as per ICH guidelines.