AQbD-Based Green and Sustainable RP-HPLC Method for Pranlukast: A Stability-Indicating and Statistically Optimized Approach

This study reports the development of a green, robust, and stability-indicating RP-HPLC method for Pranlukast Hemihydrate (PLK), a leukotriene receptor antagonist, used in asthma and allergic rhinitis. An Analytical Quality by Design (AQbD) approach with factorial design optimized the key parameters (methanol concentration, buffer pH, and flow rate) affecting chromatographic performance. Separation was achieved on a C۱۸ column using methanol: ammonium acetate buffer (۷۵:۲۵ v/v) at ۱.۲ mL/min with detection at ۲۳۰ nm. The method showed excellent linearity (۰.۱–۱۰۰ µg/mL, R² = ۰.۹۹۹), accuracy, precision (RSD < ۲%), and sensitivity (LOD ۴.۶۳ µg/mL, LOQ ۱۴.۰۳ µg/mL). Forced degradation studies confirmed the specificity and stability-indicating capability. Greenness was assessed using the AGREE, GAPI, and AES metrics to confirm environmental compatibility. The validated method was successfully applied to PLK quantification in formulations, demonstrating its suitability for routine quality control and regulatory applications.

کلیدواژه ها:

Pranlukast Hemihydrate ، RP-HPLC ، AQbD ، Green Analytical Chemistry ، Method Validation ، Forced degradation