Simultaneous Spectrophotometric Estimation of Bisoprolol Fumarate and Hydrochlorothiazide in Tablet Formulation using Partial Least-Squares, Principal Component Regression Multivariate Calibrations and RP-HPLC Methods
- Journal of Analytical & Pharmaceutical Research
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Ahmed Mostafa1*, Alaa El-Gindy2 and Samy Emara3
Department of Pharmaceutical Chemistry, University of Dammam, Saudi Arabia - Alaa El-Gindy, Department of Pharmaceutical Analytical Chemistry, Suez Canal University, Egypt
- Samy Emara, Faculty of Pharmacy, Misr International University, Egypt
Abstract
The UV spectrophotometric analysis of a binary mixture containing bisoprolol fumarate (BS) and hydrochlorothiazide (HZ) by using multivariate calibration methods, such as principal component regression (PCR) and partial least-squares regression (PLS-1); and a graphical spectrophotometric method such as second derivative of the ratio spectra 2DD was described. A calibration set of 22 reference samples was used to develop the models for PCR and PLS-1. The calibration models optimization was achieved through the proper wavelength ranges selection, and excluding any information about the interfering excipients. In addition, a High Performance Liquid Chromatography (HPLC) was developed to analyze the same mixture. The chromatographic separation was achieved on a reversed phase, RP 18 column with mobile phase consisting of acetonitrile-0.01 M KH2PO4 (40:60, v/v, and pH 3.5). Quantitation was achieved with UV detection at 232 nm based on peak area. The proposed methods were validated and successfully used for the analysis of laboratory-prepared mixtures and pharmaceutical formulations.
Keywords
Bisoprolol Fumarate, Hydrchlorothiazide, Chemometrics, Second Derivative of the Ratio Spectra, BSPCR: Principal Component Regression, PLS: Partial Least-Squares Regression, HPLC: High Performance Liquid Chromatography, ALS: Alternating Least Squares, UPLC: Ultra Pressure Liquid Chromatography
