Functional spectrum of an HPTLC analysis station in a hospital pharmacy quality assurance program.

As part of the development of a quality assurance program (CAP), a high per formance thin layer chromaiography (HPTLC) analysis unit was installed in t he pharmacy department at Gustave-Roussy: The HPTLC-CAMAG(R) consists of: 1 ) an HPTLC-Vario(R) development chamber for optimization of the mobile phas es; 2) TLC Sampler III(R) automated sample applicators, 3) solid teflon mig ration chambers, ie., horizontal tanks that enable separation to be carried out either in sandwich or in saturation mode; 4) a TLC Scanner 3(R) densit ometer controlled by CATS 4(R) software, and 5) a Pentium MMX 233 MHz perso nal computer with an external backup unit. HPTLC quantitative and qualitati ve analysis has now reached a remarkably high level of development and perf ormance. The samples (aqueous or non-aqueous solutions) that are to be proc essed are automatically applied by spraying (50-300 nl) in calibrated bands of a few mm (with up to 64 3-mm bands per 10 x 20 cm plate) on high-perfor mance stationary phases and of wide technological diversity. The chromatogr am is obtained in 10 min, and run over a migration pathway of 5-6 cm. The p lates are read by absorption-reflection or fluorescence-reflection at an ad hoc wavelength (190-800 nm), then the peak areas which have been scanned a re calculated by the trapezoid method. The calibration curves are generated by Michaelis-Menten non-linear regression, and validated by internal quali ty control. The analytical yield is high, i.e., up to 50 assays and 250 det erminations per day. HPTLC analysis covers a wide functional range, and can be used in the following ways: 1) as a teaching tool for separative analys is and GLP; 2) if is an invaluable method for the optimization of mobile ph ases and for the determination of absorption spectra and absorption maxima, with a view to developing HPLC methods in complex matrices; 3) it provides major support for post-production quality control of prescribed hospital p reparations of all types, e.g., those connected with parenteral nutrition, chemotherapy, synthetic narcotic analgesia; and ii can also be used for dry dosage analysis; 4) it is useful in pharmaceutical assessment, e.g., in st udies on the physico-chemical characteristics of various substances, such a s their identity purity, concentration, stability and compatibility particu larly with regard to generic products; 5) it can contribute to monitoring t he safety of medical apparatus and equipment via the analysis of container- content interactions; 6) it provides a qualification system for personnel a nd procedures for within- and between-center validation of GMP. Setting up such an HPTLC quality control unit requires a basic investment of about 0.9 MF or 70,000 US dollars for a cost of no more than 10 F or 1.5 US dollars (including tax) per routine assay. After 18 months in operation and 16 500 assays, the HPTLC analysis unit has become one of the mainstays of the Gust ave-Roussy QAP. (C) 2001 Editions scientifiques et medicales Elsevier SAS.