title: Development and validation of chemometrics-assisted spectrophotometric and liquid chromatographic methods for the simultaneous determination of two multicomponent mixtures containing bronchodilator drugs.
abstract: Three methods are developed for the determination of two multicomponent mixtures containing guaiphenesine (GU) with salbutamol sulfate (SL), methylparaben (MP) and propylparaben (PP) [mixture 1]; and acephylline piperazine (AC) with bromhexine hydrochloride (BX), methylparaben (MP) and propylparaben (PP) [mixture 2]. The resolution of the two multicomponent mixtures has been accomplished by using numerical spectrophotometric methods such as partial least squares (PLS-1) and principal component regression (PCR) applied to UV absorption spectra of the two mixtures. In addition HPLC method was developed using a RP 18 column at ambient temperature with mobile phase consisting of acetonitrile-0.05 M potassium dihydrogen phosphate, pH 4.3 (60:40, v/v), with UV detection at 243 nm for mixture 1, and mobile phase consisting of acetonitrile-0.05 M potassium dihydrogen phosphate, pH 3 (50:50, v/v), with UV detection at 245 nm for mixture 2. The methods were validated in terms of accuracy, specificity, precision and linearity in the range of 20-60 microg ml(-1) for GU, 1-3 microg ml(-1) for SL, 20-80 microg ml(-1) for AC, 0.2-1.8 microgml(-1) for PP and 1-5 microg ml(-1) for BX and MP. The proposed methods were successfully applied for the determination of the two multicomponent combinations in laboratory prepared mixtures and commercial syrups.
authors.affiliation: Pharmaceutical Analytical Chemistry Department, Faculty of Pharmacy, Suez Canal University, Ismailia 41522, Egypt. chemomet78@yahoo.com
authors.forename: Alaa
authors.initials: A
authors.lastname: El-Gindy
authors.forename: Samy
authors.initials: S
authors.lastname: Emara
authors.forename: Heba
authors.initials: H
authors.lastname: Shaaban
mesh_terms: D000420:Albuterol / Q000032:analysis; D001964:Bromhexine / Q000032:analysis; D001993:Bronchodilator Agents / Q000032:analysis*; D002138:Calibration; D002853:Chromatography, Liquid; D004338:Drug Combinations; D005100:Expectorants / Q000032:analysis; D006140:Guaifenesin / Q000032:analysis; D007202:Indicators and Reagents; D016018:Least-Squares Analysis; D010226:Parabens / Q000032:analysis; D000077489:Piperazine; D010879:Piperazines / Q000032:analysis; D012015:Reference Standards; D015203:Reproducibility of Results; D012997:Solvents; D013056:Spectrophotometry, Ultraviolet; D013806:Theophylline / Q000031:analogs & derivatives / Q000032:analysis
chemical_list: D001993:Bronchodilator Agents; D004338:Drug Combinations; D005100:Expectorants; D007202:Indicators and Reagents; D010226:Parabens; D010879:Piperazines; D012997:Solvents; D000077489:Piperazine; D006140:Guaifenesin; C015358:methylparaben; D013806:Theophylline; C019140:acefylline; D001964:Bromhexine; D000420:Albuterol; C006068:propylparaben