Interest of UV-Raman spectrometry for the analytical control of solid hospital preparations : development for spironolactone capsules

Introduction

Dosage and drug identification are mandatory for the liberation of hospital preparations. An UV visible/Raman atomic absorption spectrophotometer (QCRx) is already used for the preparations of cytotoxics. Therefore, we decided to develop this technique for the analytic control of other hospital preparations like capsules. In the National Formulary, the analytic control of spironolactone capsules have to be done with UV/visible spectrometry. That’s why we developed this technic for this solid preparation.

Material and methods

First, the appropriate solvent was searched based on the National Formulary: a mix water/ethanol 96% 50/50 V/V was therefore selected. The solvent was unknown to the QCRx software so it was added to the program in order not to have a solvent effect. A new library was created in the software for the analytic control of solid forms. A calibration range with 7 points was realized.

Results

The most appropriate spectral band was defined (237 nm). A good linearity (r > 99), precision (CV 0,5 %) and exactitude was obtained.

Discussion-conclusion

The analysis with the QCRx has the benefit to be automated, easy to use and permits to detect preparation errors. There are computer recorded results and this technique permits to confirm content identification. This study shows that the QCRx can be used for the analytic control of solid hospital preparations. This new technique will be tested when spironolactone capsules will be prepared for routine with an acceptability limit of ± 10%. This tool will soon be used for content uniformity with the same acceptability limit. The study will continue with other solid forms prepared in the hospital pharmacy in order to routinely control them.