Farzana S Bandarkar1 
,
Pradeep R Vavia2
For correspondence:- Farzana Bandarkar Email: farzana@hsc.edu.kw Tel:0096524986901
Received: 23 Nov 2008 Accepted: 3 Mar 2009 Published: 23 June 2009
Citation: Bandarkar FS, Vavia PR. A Stability Indicating HPLC Method for the Determination of Meloxicam in Bulk and Commercial Formulations. Trop J Pharm Res 2009; 8(3):257-264 doi: 10.4314/tjpr.v8i3.10
© 2009 The authors.
This is an Open Access article that uses a funding model which does not charge readers or their institutions for access and distributed under the terms of the Creative Commons Attribution License (http://creativecommons.org/licenses/by/4.0) and the Budapest Open Access Initiative (http://www.budapestopenaccessinitiative.org/read), which permit unrestricted use, distribution, and reproduction in any medium, provided the original work is properly credited..
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 4–20mg/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.
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