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1 2010

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Simultaneous RP-IP-HPLC assay of theophylline, phenobarbital, codeine, and ephedrine in a suppository

Jankovics P, Németh T, Németh-Palotás J, Kőszegi-Szalai H

Acta Chromatographica

2010

Vol. 22, no. 4

527--538

A reversed-phase ion-pairing liquid chromatographic (RP-IP-HPLC) method for simultaneous assay of theophylline (TH), phenobarbital (PB), codeine (CD), and ephedrine (EP) in an extemporaneous (magistral) suppository was developed and validated and used to investigate a reported serious adverse event. Samples were dissolved in dichloromethane and extracted by two-step liquid-liquid extraction with acetate buffer (pH 5.0) and, subsequently, 0.1 M NaOH solution. Separation was performed on an end-capped C 18 silica column with stepwise gradient elution. Sample preparation and chromatographic conditions were optimized on the basis of the p K a values of the analytes. Freedom from interference from the excipients, linearity ( r 2 > 0.999 for all the active ingredients), range (0.01–0.08 mg mL -1 for TH, CD, and EP; 0.0025–0.02 mg mL -1 for PB), intra-day and inter-day precision, and accuracy (recovery >95% for TH, CD, and EP and >90% for PB) of the method were demonstrated. Non-compliance of the examined product was confirmed.