DEVELOPMENT AND VALIDATION OF RP- HPLC METHOD OF LORNOXICAM FOR STABILITY INDICATING ASSAY
Journal Title: Asian J of Pharm Sci & Tech - Year 2014, Vol 4, Issue 1
Abstract
ABSTRACT Objective: The objective of the current study was to develop and validate a simple, accurate, precise and selective stability-indicating gradient reverse phase high performance liquid chromatographic method for estimation of Lornoxicam in pharmaceutical formulation in presence of degradation products. Material and methods: The chromatographic separation of Lornoxicam was achieved on Shimadzu LC-20AT series HPLC having C18-ODS bonded column (250 ×4.6 mm, 40 °C, 10 μL) using UV/Visible detector at 371 nm. The optimized mobile phase was consisted of a Methanol : acetonitrile : Water (50:30:20) at a flow rate of 1.0 mL/min. The retention times were 7.212 min for Lornoxicam. Results and Discussion: The proposed method provided linear responses within the concentration ranges 5-25µg/mL for Lornoxicam. The limit of detection (LOD) and limit of quantification (LOQ) values were found to be 0.0259µg/mL and 0.0206µg/mL for Lornoxicam. The developed method was validated as per ICH guidelines with respect to specificity, linearity, accuracy, precision, robustness and ruggedness. Conclusions: The studies data revealed that developed method was convenient, fairly reliable, sensitive, less expensive and reproducible. Key words: RP-HPLC, Validation, Stability-indicating assay, Lornoxicam.
Authors and Affiliations
Pratiksha Shrivas, Nivrati Jain, Harshita Jain, Sunil Kumar Jain, Prateek Kumar Jain, Ashish Kumar Jain*
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