VALIDATION STUDY FOR PARACETAMOL DETERMINATION IN LIQUID PRODUCTS (PARACEROL) USING RAMAN SPECTROSCOPYAbstract
In this study, Raman spectroscopy was used as an analytical quality control methodology to evaluate the paracetamol (PCT) quantity in a commercially available formulation in the pharmaceutical industry. The Raman Spectroscopy has been established for the validation and the quantification of PCT in a commercial product called Paracerol (Prc) Solution for I.V. Infusion containing 10.0 mg.mL-1 PCT. The validation of the proposed method was performed by evaluating the specificity, linearity range, accuracy, precision, detection limit, quantification limit, and robustness parameters. The acceptable results for all parameters showed that the proposed method is valid. The Raman spectroscopic method was also compared with the HPLC method in terms of PCT determination and statistical tests such as t and F tests and the obtained results indicated that there is no any difference in the averages and precision results between the proposed Raman spectroscopy and HPLC methods. It has been reported that Raman spectroscopy can be applied in the pharmaceutical industry for the quality control analysis of the commercial formulation of PCT.
T. Kocaağa, F. Yıldırım, U. Kumrulu, E. Kumrulu, N. Mutlu, E. Sopacı, B. Demirdoğan and D. Giray Dilgin *
Secondary Science and Mathematics Education Department, Faculty of Education, University of Çanakkale Onsekiz Mart, Çanakkale, Turkey.
12 April 2021
15 June 2021
21 June 2021
01 February 2022