Romanian Society of Pharmaceutical Sciences
 

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DIRECT QUANTIFICATION OF MELOXICAM FROM TRANSDERMAL THERAPEUTIC SYSTEMS BY NIR SPECTROSCOPY

PAULA ANTONOAEA1, BIANCA SYLVESTER2*, IOAN TOMUŢĂ2, ADRIANA CIURBA1, EMÖKE RÉDAI1, NICOLETA TODORAN1, DANIELA LUCIA MUNTEAN3

1.Department of Pharmaceutical Technology, Faculty of Pharmacy, University of Medicine and Pharmacy Târgu Mureş, 540139, Romania
2.Department of Pharmaceutical Technology and Biopharmaceutics, Faculty of Pharmacy, “Iuliu Haţieganu” University of Medicine and Pharmacy, Cluj-Napoca, 400012, Romania
3.Department of Analytical Chemistry and Drug Analysis, Faculty of Pharmacy, University of Medicine and Pharmacy Târgu Mureş, 540139, Romania

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This study describes the development and validation of a new near infrared (NIR) spectroscopic method for the determination of meloxicam content from transdermal therapeutic systems (TTS). For this purpose, it was developed a calibration model based on an experimental design with 1 factor (meloxicam) and 5 levels (5 concentrations corresponding to 80%, 90%, 100%, 110% and 120% pharmaceutical active ingredient/TTS); in total 15 samples were prepared. For the validation set, 36 samples were prepared with concentrations corresponding to 90%, 100% and 110% meloxicam/TTS. Satisfactory results were acquired with the use of a spectral region 7872.5 - 5797.3 cm-1, using first derivation (FD) followed by standard normal variate (SNV) pre-treatment method and 8 PLS (partial least squares) factors. According to the International Council for Harmonisation (ICH) guidance, the method was validated in terms of accuracy, precision and trueness. Compared to HPLC reference method, the value resulted by applying the NIR method showed no statistical differences (p > 0.05). Therefore, this method can be applied for the direct quantification of meloxicam from TTS. Also, as is a non-invasive and fast method, NIR spectroscopy is suitable to on/at line monitoring of the active substance content from TTS.