Simultaneous determination of some active ingredients in cough and cold preparations by gas chromatography, and method validation.
A simple and rapid gas chromatographic (GC) method has been developed for the simultaneous determination of combinations of acetaminophen, phenylpropanolamine hydrochloride, guaifenesin, pseudoephedrine hydrochloride, caffeine, chlorpheniramine maleate, and dextromethorphan hydrobromide in cough and cold tablets and syrups. After extraction of the analyte with alkaline ethyl acetate, 2 microL extract was injected (splitting ratio of 50:1) into a gas chromatograph equipped with a CBP1-M25-025 fused silica capillary column (25 m x 0.22 mm; film thickness, 0.25 microm). The column temperature was held at 150 degrees C for 5 min, increased to 175 degrees C at 3 degrees C/min, and increased to 270 degreesC at 10 degrees C/min. The temperatures of the flame ionization detector and injector were maintained at 300 degrees C. The GC method is inexpensive, rapid, accurate, and precise, and thus it can be used for routine analysis of tablet and syrup preparations in quality control laboratories of pharmaceutical companies.
Harsono
Thresiana
T
PT Bernofarm Pharmaceutical Co., QC-Laboratory, Buduran, Sidoarjo 61252, Surabaya, Indonesia.
Yuwono
Mochammad
M
Indrayanto
Gunawan
G
D000082:Acetaminophen / Q000032:analysis; D000085:Acetates / Q000032:analysis; D000704:Analysis of Variance; D000996:Antitussive Agents / Q000032:analysis*; D002110:Caffeine / Q000032:analysis; D002626:Chemistry, Pharmaceutical / Q000379:methods*; D002744:Chlorpheniramine / Q000032:analysis; D002849:Chromatography, Gas / Q000379:methods*; D003915:Dextromethorphan / Q000032:analysis; D004338:Drug Combinations; D019075:Electrophoresis, Capillary / Q000295:instrumentation / Q000379:methods; D004809:Ephedrine / Q000032:analysis; D005100:Expectorants / Q000032:analysis*; D006140:Guaifenesin / Q000032:analysis; D014663:Nasal Decongestants / Q000032:analysis; D010665:Phenylpropanolamine / Q000032:analysis; D015203:Reproducibility of Results; D012984:Software; D013678:Technology, Pharmaceutical / Q000379:methods*; D013696:Temperature; D013997:Time Factors; D014465:Ultrasonics
D000085:Acetates; D000996:Antitussive Agents; D004338:Drug Combinations; D005100:Expectorants; D014663:Nasal Decongestants; D010665:Phenylpropanolamine; D000082:Acetaminophen; D002110:Caffeine; D002744:Chlorpheniramine; D006140:Guaifenesin; D003915:Dextromethorphan; C007650:ethyl acetate; D004809:Ephedrine