Abstract

BETA CARYOPHYLLENE OXIDE QUANTIFICATION BY UV SPECTROSCOPY: METHOD DEVELOPMENT AND OPTIMIZATION BY ICH GUIDELINES

Jyotsana Sonkar1,, Sarita Kumari Yadav2, Alok Mukerjee3, Mohammed Ibrahim Khan1, Danish Ahmed*1
1. SHUATS, SIHAS, Naini, Prayagraj-211007 2. Department of Pharmacy, M.L.N. Medical College, UP, Prayagraj-211002, 3. United Institute of Pharmacy, Naini, Prayagraj (UP) 211004, India

Abstract

UV-Spectrophotometric method was carried out for profiling of phytochemicals .The method of analysis of Beta Caryophyllene oxide (BCO) in the lab has been developed. BCO exhibited absorption maximum of 285 nm. Analytical parameter including linearity and range, precision, accuracy, robustness and ruggedness were established following the International Conference on Harmonization (ICH) guidelines. The calibration curve showed a linear response according to Beer-Lambert's law for BCO concentration ranging from 0.1 to 0.9 mg/ml, with a correlation coefficient of 0.9963. Accuracy ranged from 99.78 to 102.24, while precision, expressed as relative standard deviation (% RSD) was 1.1164 % (Intraday) and 0.6948% (Interday) across nine sample preparations. The method's sensitivity was demonstrated by a limit of detection (LOD) of 0.0378 mg/ml and limit of quantification (LOQ) of 0.1147 mg/ml. Ruggedness, assessed by two analysts, showed %RSD values 0.801% and 0.751%. Robustness was evaluated at three wavelengths (284 nm, 285 nm, and 286 nm) yielding values of 1.705, 1.581, and 1.695, respectively. The study concluded that developed method was linear, accurate, precise, and cost-effective. It is suitable for routine analysis of BCO formulations.
Keyword: ICH guidelines, standard curve, Beer-Lambert’s Law, Accuracy, Precision