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Original
Research Article
A Stability
Indicating HPLC Method for the Determination of
Meloxicam in Bulk and Commercial Formulations
Farzana S
Bandarkar1* and Pradeep R Vavia2
1Department
of Pharmaceutics, Faculty of Pharmacy, Kuwait
University, Kuwait, 2Faculty of Pharmacy,
University Institute of Chemical Technology, Mumbai,
India
*For correspondence:
E-mail:
farzana@hsc.edu.kw
or
pradeepvavia@yahoo.com Tel: 00965 24986901;
Mobile:
00965 99537507; Fax: 00965-4986843
Received: 23 Nov
2008
Revised accepted: 3 Mar 2009
Tropical
Journal of Pharmaceutical Research, June 2009; 8(3):
257-264
Abstract
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.
Keywords: Meloxicam, Reverse phase stability
indicating HPLC, Stress degradation, Bulk and commercial
formulations. |
