Eco-Friendly Stability-Indicating HPLC Method for Related Compounds in Pemetrexed Ditromethamine (Antineoplastic Agent) for Injection

Background: The Eco-friendly analytical technique was developed for intention of preserving the environment by using green chemistry principles. Pemetrexed is folate analogue indicated for treatment of advanced lung cancer. Objective: Development of Green Stability indicating HPLC method for quantification of Pemetrexed (Ditromethamine) impurities in API and parenteral dosage form. Method: Chromatographic separation was achieved by using Zorbax SB C18 column (150 mm x 4.6 mm inner diameter, 3.5 mu particle size) with perchlorate buffer (pH 3.0 +/- 0.1, 50 mM) as a mobile phase-A and Acetonitrile-perchlorate buffer (90 + 10, v/v) as a mobile phase-B at a flow rate of 0.8 mL/minute with column temperature 40 degrees C +/- 0.5 degrees C. All analytes were well resolved by gradient elution with total run time of 75 minutes and detection wavelength at UV 230 nm. Results: The RP-HPLC method is capable to resolve all the degradation and process impurities for Pemetrexed Ditromethamine API and parenteral dosage form. The related compounds method was validated in accordance with ICH Q2(R1) and USP <1225> guidelines, found to be accurate, specific, precise, linear, robust and stability indicating. The precision and intermediate results shown the below < 5% CV values for all the impurities. The accuracy of all the impurities were found to be between 90% and 110%. The linearity of regression co-efficient values for all the impurities were found to be more than 0.999. Conclusion: The proposed related compounds method is found suitable for the determination of process and degradation impurities of commercial formulations, stability samples in quality control analysis for Pemetrexed Ditromethamine (PDT) API and drug product.