DEVELOPMENT AND VALIDATION OF RP-HPLC METHOD FOR THE ESTIMATION OF ESCITALOPRAM OXALATE AND FLUPENTIXOL DIHYDROCHLORIDE IN COMBINED DOSAGE FORM AND FROM PLASMA
Objective: The objective of the study is to develop a simple and rapid chromatographic method for quantification of escitalopram oxalate and flupentixol dihydrochloride in combined dosage form and from plasma.
Methods: Separation was achieved with an sunfire C8 (150Ã—4.6 mm) 3.5Âµm column with an isocratic mobile phase containing a mixture of potassium dihydrogen orthophosphate buffer: methanol: acetonitrile (30:60:10 v/v/v) pH adjusted to 11. The flow rate of the mobile phase was 1.5 ml/min with PDA detection at 230 nm.
Results: Â The HPLC method was developed and validated with respective linearity, accuracy, precision, detection of limit, robustness, and specificity. The precision of the results, stated as the relative standard deviation was below 2%. The calibration curve was linear over a concentration range from10-50Âµg/ml for escitalopram oxalate and 1-5 Âµg/ml for flupentixol dihydrochloride with a correlation co-efficient 0.994 and 0.977 respectively. The accuracy of the method demonstrated atÂ levels in the range of 100% and 120% of the specification limit. The recovery of Â escitalopram oxalate and flupentixol dihydrochloride was found to be in the range of 90% to 88% for escitalopram oxalate and 89% to 88% for flupentixol dihydrochloride. The lowest detection limits were found to be 2 Âµg/ml for escitalopram oxalate and 0.1 Âµg/ml for flupentixol dihydrochloride. The lowest quantification limits were found to be 5 Âµg/ml of escitalopram oxalate and 0.5 Âµg/ml of flupentixol dihydrochloride.Conclusion: The developed method was validated with respect to linearity, accuracy, precision, limit of detection and quantification, specificity. The method was applied successfully for the determination of escitalopram oxalate and flupentixol dihydrochloride in combined Â dosage form
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