A Green Stability Indicating Method for Quantification of Meloxicam Using Quality by Design Principles

Abstract

Objective: To develop and validate an analytical quality by design (AQbD) guided stability indicating high-performance liquid chromatography (HPLC) method for the estimation of meloxicam in bulk drug and tablet formulations. Methods: A systematic AQbD approach was employed using Box–Behnken Design (BBD) to evaluate the influence critical method parameters (CMP) on critical analytical attributes (CAA). Chromatographic separation was achieved on a C18 column using a mobile phase consisting of acetonitrile (ACN) and 0.1% orthophosphoric acid (75:25 % v/v). The flow rate was 1.0 ml/min with a column temperature of 45 °C, and detection was performed at 364 nm. The stability-indicating capability of the method was assessed through forced degradation studies. The developed method was validated as per ICH Q2(R1) guidelines. Results: Meloxicam was well resolved from its degradation products with a retention time of 3.63 min. The method exhibited good linearity in the concentration range of 2-18 µg/ml with a correlation coefficient (r²) of 0.9975. The limit of detection (LOD) and limit of quantification (LOQ) were found to be 0.14 µg/ml and 0.45 µg/ml, respectively, indicating good sensitivity. The method demonstrated satisfactory accuracy with percentage recovery of 98.3% to 100.6% and high precision with %RSD<2%. The developed method was successfully applied to the assay of meloxicam in tablet formulations, confirming its suitability for routine analysis. The greenness of the method was also evaluated using the AGREE tool. Conclusion: The developed AQbD-based stability-indicating HPLC method is robust, accurate, precise, and environmentally acceptable. The method is suitable for routine quality control and stability analysis of meloxicam in bulk and pharmaceutical dosage forms.