Development of UV-Raman spectrometric analytical control applied to eyedrops hospital preparations

Introduction

Fortified eyedrops are the preferred treatment for keratitis. In this context, amphotericin B, amikacine, gentamicine, ceftazidime and vancomycine eyedrops were prepared. An analytic control with dosage and identification is essential for these sterile hospital preparations. Therefore, an UV visible/Raman atomic absorption spectrophotometer (QCRx) was used to analyse the eyedrops.

Material and methods

The most appropriate spectral bands were defined for each eyedrops. They were : gentamicine : 850 nm, ceftazidime : 342 nm, vancomycine : 300 nm, amphotericin B : 243 nm and amikacine : 219 nm. A solution sample is collected in a vial for each lot produced and it is analysed with the QCRx. Then, the software checks the correlation between the expected datas and the sample (solvent, drug, solution concentration (acceptation limit : 15 %)).

Results

The method was validated with the solvents for each eyedrops (repetability, reproductibility, precision with CV ¡Ü 2,8%, linearity with r > 99 %). The QCRx had permitted to detect a preparation mistake : a dilution had been forgotten, which conduced to prepare another eyedrops.

Discussion-conclusion

The QCRx permits to detect preparation errors, to secure the fabrication and to question practices (homogenization lack). It doesn’t need extraction contrary to HPLC and is easy to use, reliable, automated with computer recorded results. This tool will be soon used for content uniformity thanks to an Excel file which will be interfaced with QCRx software.