White Analytical Perspective on Lamivudine Determination: HPLC-PDA and HPLC-ELSD Method Development, Validation, and...

Area of Science:

• Analytical Chemistry
• Pharmaceutical Analysis
• Green Chemistry

Background:

• Lamivudine (LMV) is a critical antiviral medication for HIV and Hepatitis B.
• Accurate and sustainable analytical methods are essential for pharmaceutical quality control.

Purpose of the Study:

• To develop and validate rapid, accurate, and eco-friendly High-Performance Liquid Chromatography (HPLC) methods for lamivudine quantification.
• To assess the environmental and practical sustainability of the developed HPLC methods using established green chemistry metrics.
• To compare the performance of HPLC coupled with Photodiode Array (PDA) and Evaporative Light Scattering Detector (ELSD) systems for lamivudine analysis.

Main Methods:

• Development and validation of HPLC methods using a C18 column and an isocratic ethanol-water mobile phase.
• Quantification of lamivudine in pharmaceutical formulations.
• Validation according to ICH Q2-(R2) guidelines, including specificity, linearity, precision, accuracy, sensitivity, and robustness.
• Sustainability assessment using tools like AGREE, AES, MoGAPI, BAGI, and CACI within the White Analytical Chemistry (WAC) framework.

Main Results:

• Both HPLC-PDA and HPLC-ELSD methods demonstrated excellent linearity (R² > 0.997) and high accuracy (98.56-101.42% recovery) with good precision (RSD < 2%).
• High greenness scores (AGREE, AES, MoGAPI) and strong applicability/practicality (BAGI, CACI) confirmed the sustainability of both methods.
• The HPLC-ELSD method showed slightly lower 'whiteness' due to higher LOQ and energy use, but both were deemed acceptable.

Conclusions:

• The developed HPLC methods (PDA and ELSD) are rapid, accurate, and environmentally compatible for lamivudine analysis in pharmaceutical formulations.
• These methods align with White Analytical Chemistry principles, offering sustainable, reliable, and cost-effective analytical solutions.
• The study provides validated, green analytical approaches suitable for routine pharmaceutical quality control.