Ecofriendly Validated Chromatographic Methods for Quantitation of Cyclizine and Its Toxic Impurities in Its Parenteral Formulation.

Cyclizine (CYZ) abuse is commonly reported, either through oral or intravenous routes, for its euphoric or hallucinatory effects. The concomitant misuse of CYZ among addicted teenagers leads to life-threatening neuromuscular disorders. Consequently, two green and validated chromatographic methods were developed for the determination of CYZ, an antiemetic drug, in its parenteral formulation in the presence of 1-methyl piperazine and diphenylmethanol (benzhydrol) as the pharmacopeial stated impurities of CYZ. The first method was TLC-densitometry that relied on using a mixture consisting of ethyl acetate:isopropanol:ammonia (9.5:1:0.5, by volume) as a developing system, TLC 60 F₂₅₄ silica gel plates as a stationary phase and detection of the scanned bands was performed at 210.0 nm. On the other hand, the second method was UPLC which based on the separation of CYZ and its impurities using a mobile phase consisting of ethanol and acidic water at pH 5 adjusted by phosphoric acid in the ratio of (60:40, %v/v) at flow rate 0.2 mL min⁻¹ and UV detection were carried out at 210.0 nm. The greenness profile of the established methods was evaluated and calculated for the first time for CYZ and its toxic impurities through different assessment tools like analytical eco-scale, analytical method volume intensity and greenness profile methods. Validation of the developed methods was carried out in accordance with the guidelines of the International Conference on Harmonization. The suggested methods were accurate, reliable, time and cost-saving. Therefore, they could be used in quantification of CYZ abuse and its toxic impurities in parenteral formulation for routine quality control. The results achieved by applying the suggested methods were statistically analyzed and compared with those given by reported one and no significant differences were obtained regarding both precision and accuracy. [ABSTRACT FROM AUTHOR]