Use of chemometrics for development and validation of an RP-HPLC method for simultaneous determination of haloperidol and related compoundsReportar como inadecuado




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Acta Pharmaceutica, Vol.58 No.3 September 2008. -

A rapid resolution reversed-phase high performance liquid chromatographic RR RP-HPLC method has been developed and validated for simultaneous determination of haloperidol and six related compounds. Investigated matrix was a laboratory mixture of the therapeutic active substance haloperidol and its six related compounds in a concentration ratio 300:1. Experimental design was used during method optimization full factorial 23 design and robustness testing Central Composite Circumscribed design. Three factors: organic phase variation during gradient elution, flow rate and gradient rise time were independent variables. To estimate the system response during the optimization procedure and robustness testing, resolution Rs and a chromatographic response function CRF were used. Chromatography was performed with the mobile phase containing phosphate buffer pH 6.5 and acetonitrile as organic modifier. Separation was achieved using gradient elution organic phase fraction changed linearly from 20 to 72% over 7 min. A Zorbax Eclipse XDB C18 Rapid Resolution HT 4.6 mm × 50 mm, 1.8 μm particle size, column was used at 25 °C at a flow rate of 1.5 mL min−1. UV detection was performed at 230 nm. The total time for chromatographic separation was 5.5 min with a total analysis time of 7.0 min. The method was validated for its linearity, precision, modal recovery and robustness.

haloperidol; impurities; RP-HPLC; validation; experimental design



Autor: RUMENKA PETKOVSKA - ; Department of Chemistry, Faculty of Pharmacy -Ss. Cyril and Methodius- University, 1000 Skopje, Macedonia A

Fuente: http://hrcak.srce.hr/



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