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
1Department of Pharmaceutical Technology, Faculty of Pharmacy, University of Medicine and Pharmacy Târgu Mureş,
540139, Romania
2Department of Pharmaceutical Technology and Biopharmaceutics, Faculty of Pharmacy, “Iuliu Haţieganu” University of
Medicine and Pharmacy, Cluj-Napoca, 400012, Romania
3Department of Analytical Chemistry and Drug Analysis, Faculty of Pharmacy, University of Medicine and Pharmacy Târgu
Mureş, 540139, Romania
*corresponding author: biancasylvester@ymail.com
Download Full Article

Abstract:
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.

Top