Abstract
A traditional dissolution pumping system was recently replaced with a fiber optic interface between the spectrometer and the samples. However, the system was limited to a single sample vessel. In this study, a dissolution testing system with six vessels connected to a diode array spectrometer via six optical fibers was investigated. A bifurcated fiber optic bundle was used to transfer the light from the source to the dissolution vessels and was networked so that spectra of each sample can be measured periodically. A full spectrum calibration method based on Principal Component Regression (PCR) was used to determine the concentrations of active ingredients and to account for interferences due to excipients in tablet formulations. Results on this new fiber optic interface system are compared with those obtained previously with the traditional pumping system. Standard errors of prediction are between 1.5 and 3.2% using cross-validation and between 1.1 and 1.7% for the direct validation of two active ingredients in two different drug formulations.
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REFERENCES
U. S. Pharmacopeia, 21st rev.; The National Formulary XVI. United States Pharmacopeial Convention, Inc., Rockville, MD. 1985.
D. E. Wurster, W. A. Wargin, and M DeBerardinis Jr. Automated dissolution testing of combination drug product using high-pressure liquid chromatography. J. Pharm. Sci. 70:764–767 (1981).
R. Soltero, J. Robinson, and D. Adair. Dissolution profile determination of a multicomponent product using a rapid liquid chromatography. J. Pharm. Sci. 73:799–803 (1984).
E. Lamparter, C. Lunkenheimer, and U. Seibel. Application of multicomponent analysis in pharmaceutical dosage forms. GIT Fachz Lab. 3:313–321 (1990).
S-C. Lo, S M. Donahue, and C. W. Brown. Automated drug dissolution monitor that uses a UV-Visible diode array spectrophotometer. J. Pharm. Sci. 82:350–354 (1993).
F. J. Cioffi, H. M. Abdou, and A. T. Warren. Computerized automated system for determining dissolution rate profiles for solid dosage form. J. Pharm. Sci. 65:1234–1240 (1976).
M. Josefson, E. Johansson, and A. Torstensson. Optical fiber spectrometry in turbid solutions by multivariate calibration applied to tablet dissolution testing. Anal. Chem. 60:2666–2671 (1988).
P. J. Gemperline, and A. Salt. Principal components regression for routine multicomponent UV determinations: validation protocol. J. Chemometrics 3:343–357 (1989).
K. R. Beebe and B. R. Kowalski. An introduction to multivariate calibration and analysis. Anal. Chem. 59:1007A–1017A (1987).
C. W. Brown and S. M. Donahue. Searching a UV-Visible spectral library. Appl. Spectrosc. 42:347–352 (1988).
S. Wold, K. Esbensen, and P. Geladi. Principal component analysis. Chemometrics and Intelligent Laboratory Systems 2:37–52 (1987).
C. W. Brown, R. J. Obremski, and P. Anderson. Infrared quantitative analysis in the Fourier domain: processing vector representations. Appl. Spectrosc. 40:734–742 (1986).
C. W. Brown and J. Lin. Interfacing a fiber-optic probe to a diode array UV-visible spectrophotometer for drug dissolution tests. Appl. Spectrosc. 47:615–618 (1993).
J. Lin and C. W. Brown. Near-IR fiber-optic temperature sensor. Appl. Spectrosc. 47:62–68 (1993).
S. M. Donahue and C. W. Brown. Successive average orthogonalization of spectral data. Anal. Chem. 63:980–985 (1991).
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Chen, CS., Brown, C.W. A Drug Dissolution Monitor Employing Multiple Fiber Optic Probes and a UV/Visible Diode Array Spectrophotometer. Pharm Res 11, 979–983 (1994). https://doi.org/10.1023/A:1018975002025
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DOI: https://doi.org/10.1023/A:1018975002025