Method development and validation for the simultaneous determination of cetirizine dihydrochloride, paracetamol, and phenylpropanolamine hydrochloride in tablets by capillary zone electrophoresis.
A simple, selective, and cost effective capillary zone electrophoresis (CZE) method has been developed for the simultaneous separation and determination of cetirizine dihydrochloride (CTZ), paracetamol (PARA), and phenylpropanolamine hydrochloride (PPA) in tablets. A 10 mM sodium tetraborate background electrolyte (BGE) solution (pH 9.0) was found to be suitable for separation of all the analytes. An uncoated fused-silica capillary of a total length of 76 cm (effective length 64.5 cm) was used for separation. All the analytes were completely separated within 10 min at the applied voltage of 20 kV (current produced approximately 21 microA), and detection was performed at 195 nm with an UV detector. Ibuprofen was used as internal standard (I.S.) for the quantification of the drugs. Validation of the method was performed in terms of linearity, accuracy, precision, limit of detection (LOD), and quantification (LOQ). The linearity of the calibration curves for CTZ, PARA, and PPA (tested range) were 2-50 microg ml(-1) (r(2)=0.9982), 10-1000 microg ml(-1) (r(2)=0.9978), and 10-100 microg ml(-1) (r(2)=0.9986), respectively. The proposed method has been applied for the determination of active ingredients in tablets, and the recovery was found to be > or =98.60% with the relative standard deviation (R.S.D.) < or =1.56%. The LOQ of the CTZ, PARA, and PPA was found to be 2.0, 2.0, and 4.0 microg ml(-1), respectively. There were no interfering peaks due to the excipients present in the pharmaceutical tablets. Thus, the proposed method is simple and suitable for the simultaneous analysis of active ingredients in tablet dosage forms.
Azhagvuel
S
S
Analytical Chemistry Division, Indian Institute of Chemical Technology, Hyderabad 500007, India.
Sekar
R
R
D000082:Acetaminophen / Q000032:analysis*; D000316:Adrenergic alpha-Agonists / Q000032:analysis*; D018712:Analgesics, Non-Narcotic / Q000032:analysis*; D001881:Borates / Q000737:chemistry; D002021:Buffers; D053801:Capillary Electrochromatography; D017332:Cetirizine / Q000032:analysis*; D002851:Chromatography, High Pressure Liquid; D004338:Drug Combinations; D004355:Drug Stability; D004563:Electrochemistry; D006634:Histamine H1 Antagonists / Q000032:analysis*; D006863:Hydrogen-Ion Concentration; D007202:Indicators and Reagents; D010665:Phenylpropanolamine / Q000032:analysis*; D012015:Reference Standards; D015203:Reproducibility of Results; D013056:Spectrophotometry, Ultraviolet; D013607:Tablets
D000316:Adrenergic alpha-Agonists; D018712:Analgesics, Non-Narcotic; D001881:Borates; D002021:Buffers; D004338:Drug Combinations; D006634:Histamine H1 Antagonists; D007202:Indicators and Reagents; D013607:Tablets; D010665:Phenylpropanolamine; D000082:Acetaminophen; D017332:Cetirizine