title: Determination of phenylephrine hydrochloride, chlorpheniramine maleate, and methscopolamine nitrate in tablets or capsules by liquid chromatography with two UV absorbance detectors in series.
abstract: A procedure is presented for the simultaneous determination of phenylephrine HCI (PE), chlorpheniramine maleate (CM), and methscopolamine nitrate in commercial tablets or capsules by liquid chromatography (LC) with 2 UV absorbance detectors in series. Reference and sample solutions are prepared in methanol. LC separations are performed on a 7.5 cm Novapak silica column. The mobile phase is prepared by mixing 930 mL methanol with 70 mL of a 0.5% aqueous solution of 1-pentanesulfonic acid, sodium salt. The injection volume is 20 microL; the flow rate is approximately 1 mL/min. Retention times are approximately 1.5 min for PE, 3 min for CM, and 6 min for methscopolamine nitrate. One detector determines the first 2 compounds at 265 nm, but the third compound does not produce a detectable peak. The other detector set at 210 nm generates peaks for all 3 compounds, but only methscopolamine is within the recorder range; the other 2 compounds are exceedingly off scale. If it is not feasible or desirable to arrange 2 UV absorbance detectors in series, separate determinations can be made, one for the first 2 compounds and the other for the third component of the mixture. Two commercial samples of tablets and 2 commercial samples of capsules were analyzed by the proposed method. Recovery studies were also conducted with amounts of the 3 compounds ranging from 80 to 120% of the quantities present in the sample solutions.
authors.affiliation: U.S. Food and Drug Administration, 2nd and Chestnut Sts, Philadelphia, PA 19106, USA. ucieri@ora.fda.gov
authors.forename: Uco R
authors.initials: UR
authors.lastname: Cieri
mesh_terms: D002214:Capsules; D002623:Chemistry Techniques, Analytical / Q000295:instrumentation* / Q000379:methods*; D002744:Chlorpheniramine / Q000032:analysis* / Q000737:chemistry; D002845:Chromatography; D002853:Chromatography, Liquid / Q000379:methods*; D019832:N-Methylscopolamine / Q000031:analogs & derivatives* / Q000032:analysis* / Q000737:chemistry; D009566:Nitrates / Q000032:analysis*; D010656:Phenylephrine / Q000032:analysis*; D011786:Quality Control; D015203:Reproducibility of Results; D013053:Spectrophotometry / Q000379:methods*; D013056:Spectrophotometry, Ultraviolet / Q000379:methods*; D013607:Tablets; D013997:Time Factors; D014466:Ultraviolet Rays
chemical_list: D002214:Capsules; D009566:Nitrates; D013607:Tablets; D010656:Phenylephrine; D002744:Chlorpheniramine; D019832:N-Methylscopolamine