A Stability Indicating HPLC Method for the Determination of Meloxicam in Bulk and Commercial Formulations

Purpose: The present study was undertaken to develop a validated, rapid, simple and economic stability indicating reverse phase HPLC method for estimating meloxicam (MLX) in bulk and commercial preparations.
Method: Reversed phase chromatographic analysis was performed on a C18 Hi Q Sil column with acetonitrile-water-glacial acetic acid [55:40:5 (% v/v)] at a flow rate of 1ml/min and detection wavelength of 355 nm. System suitability tests essential for the assurance of quality performance of the method were performed. The drug was subjected to stress degradation studies under acidic, basic and oxidative conditions. The method was validated for accuracy, precision, reproducibility, specificity, robustness, limit of detection (LOD) and limit of quantification (LOQ) , as per International Conference on Harmonization (ICH) guidelines.
Results: A single sharp peak was obtained for MLX at Rt of 6.8 ± 0.01min. The polynomial regression data for the calibration plots exhibited good linear relationship (r = 0.9995) over a concentration range of 4–20µg/ml and the linear regression equation was y = 57257.38x + 3443.07. Accuracy ranged from 99.27 to 100.78% and the % coefficient of variation (CV) for both intra-day and inter-day precision was less than 2%. MLX showed minor degradation peak in acidic conditions at Rt of 2.24min. The LOD and LOQ values were 360 ng/ml and 510 ng/ml, respectively.
Conclusion: The proposed method gave good resolution of MLX and its degradants. System suitability tests and statistical analysis performed prove that the method is precise, accurate and reproducible, and hence can be employed for routine analysis of MLX in bulk and commercial formulations.

Keywords
Meloxicam, Reverse phase stability indicating HPLC, Stress degradation, Bulk and commercial formulations.