DEVELOPMENT AND VALIDATION OF RP- HPLC METHOD OF DEFLAZACORT FOR STABILITY INDICATING ASSAY
Adina Institute of Pharmaceutical Sciences, Sagar, 470002, (M.P), India
Nivrati Jain
Adina Institute of Pharmaceutical Sciences, Sagar, 470002, (M.P), India
Harshita Jain
Adina Institute of Pharmaceutical Sciences, Sagar, 470002, (M.P), India
Prateek Kumar Jain
Adina Institute of Pharmaceutical Sciences, Sagar, 470002, (M.P), India
Ashish Kumar Jain
Adina Institute of Pharmaceutical Sciences, Sagar, 470002, (M.P), India
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 simultaneous estimation of Deflazacort in pharmaceutical formulation in presence of degradation products. The chromatographic separation of Deflazacort 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 242 nm. The optimized mobile phase was consisted of a acetonitrile: Water (50:50) at a flow rate of 1.0 mL/min. The retention times were 5.254 min for Deflazacort. The proposed method provided linear responses within the concentration ranges 5-25µg/mL for bambuterol and montelukast. The limit of detection (LOD) and limit of quantification (LOQ) values were found to be 0.0259 µg/mL and 0.0206 µg/mL for Deflazacort. The developed method was validated as per ICH guidelines with respect to specificity, linearity, accuracy, precision, robustness and ruggedness. The studies data revealed that developed method was convenient, fairly reliable, sensitive, less expensive and reproducible
4 , 2 , 2014
117 - 123
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