A SIMPLE RP-HPLC METHOD FOR SIMULTANEOUS ESTIMATION OF ORGANIC IMPURITIES, ENANTIOMER AND ASSAY OF DEXLANSOPRAZOLE
Objective: To develop a simple and accurate RP-HPLC method for simultaneous estimation of organic impurities, enantiomer and assay of Dexlansoprazole, proposed method was validated according to an International Conference on Harmonisation of technical requirements for registration of pharmaceuticals for human use (ICH) guidelines.
Methods: Cellulose tris-(3,5-dichlorophenylcarbamate) bonded on silica gel (Chiralpak IC) were used as stationary phase. Acetonitrile (ACN) and 10 mM dibasic potassium phosphate buffer of pH 7.20, adjusted with dilute ortho phosphoric acid, were used as mobile phase in gradient composition at a flow rate of 1.0 ml/min. UV detection was made at 283 nm and run time was 27 min.
Results: Limit of detection (LOD) and Limit of quantification (LOQ) was 42 and 126 ng/ml, respectively. Analytes response was studied from 0.25-1.50 Âµg/ml and r2 value of the calibration curve was>0.999. Accuracy was studied in three different concentrations, the mean recovery was observed between 93.8 and 102.5%. To the maximum of 0.01% impurity variation was observed between the results of inter and intra-day precision.
Conclusion: Proposed method is specific, precise, sensitive, linear and accurate. As a significance of this proposed method, the listed known impurities of Lansoprazole monograph [United States, British and European pharmacopoeias (USP/BP/Ph. Eur.)] Were used in method development and separation was demonstrated. Apart from this, enantiomer resolution was achieved and the same chromatogram was used for assay calculation.
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