REVERSE PHASE HPLC METHOD DEVELOPMENT AND VALIDATION FOR DETERMINATION OF MELOXICAM IN BULK AND PHARMACEUTICAL FORMULATIONAbstract
Meloxicam (MEL) is an oxicam derivative and a member of the enolic acid group of non-steroidal anti-inflammatory drugs (NSAIDs). Most of the reported methods for HPLC analysis of Meloxicam are cumbersome, time-consuming and expensive. Reverse phase chromatographic analysis was performed on a C18 Hi Q Sil column with methanol–water- orthophosphoric acid (80:19.9:0.1 % v/v) at a flow rate of 1ml/min and detection wavelength of 360 nm. System suitability tests essential for the assurance of quality performance of the method were performed. The method was validated for accuracy, precision, reproducibility, specificity and robustness, limit of detection (LOD) and limit of quantification (LOQ). A single sharp peak was obtained for MEL at Rt of 4.38 ± 0.02 min. The polynomial regression data for the calibration plots exhibited linear relationship (r = 0.999) over a concentration range of 4–20µg/ml and the linear regression equation was y = 43754x – 2094. Accuracy ranged from 99.33 to 100.45% and the % coefficient of variation (CV) for both intra-day and inter-day precision was less than 2%. The LOD and LOQ values were 480 ng/ml and 680 ng/ml, respectively. The proposed method gave good resolution for MEL. System suitability tests and statistical analysis performed prove that the method is precise, accurate and reproducible, hence can be employed for routine analysis of MEL in bulk and commercial formulations.
Jessy Shaji * and Vinay Jain
Prin. K. M. Kundnani College of Pharmacy, 23, Jote Joy Building, Rambhau Salgaonkar Marg, Cuffe Parade, Colaba, Mumbai, Maharashtra, India
11 August, 2010
12 November, 2010
12 November, 2010