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

Arjuna Rao Nekkalapudi1,2, Srinivasu Navuluri1, Sreenivas Pippalla3

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A new green high-performance liquid chromatography (HPLC) method quantifies pemetrexed ditromethamine (PDT) impurities. This eco-friendly approach ensures accurate analysis of API and drug products, supporting quality control.

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Area of Science:

  • Analytical Chemistry
  • Green Chemistry
  • Pharmaceutical Analysis

Background:

  • Pemetrexed is a key folate analogue for advanced lung cancer treatment.
  • Environmental preservation through green chemistry principles is crucial in analytical techniques.
  • Impurity profiling is essential for pharmaceutical quality and patient safety.

Purpose of the Study:

  • To develop and validate a green, stability-indicating HPLC method for quantifying pemetrexed ditromethamine (PDT) impurities.
  • To ensure the method is suitable for both Active Pharmaceutical Ingredient (API) and parenteral dosage forms.
  • To assess the environmental impact and greenness of the developed analytical method.

Main Methods:

  • RP-HPLC using a Zorbax SB C18 column with a gradient elution of perchlorate buffer and acetonitrile-perchlorate.
  • Optimized flow rate (0.8 mL/min), column temperature (40°C), and UV detection at 230 nm.
  • Method validation according to ICH Q2(R1) and USP <1225> guidelines.

Main Results:

  • The method successfully resolved all process and degradation impurities for PDT API and parenteral dosage forms.
  • Validation demonstrated high accuracy (90-110%), precision (<5% CV), specificity, linearity (>0.999), robustness, and stability-indicating capability.
  • The method is accurate, specific, precise, linear, robust, and stability-indicating.

Conclusions:

  • The developed HPLC method is suitable for determining process and degradation impurities in PDT API and drug products.
  • The method's greenness and eco-friendliness were confirmed using GAPI and AGREE tools.
  • A PDT detoxification procedure was also developed to minimize environmental pollution.