Egyptian Drug Authority (EDA), 6 Abu-Hazem St. from El-Haram St, Giza, Egypt.
Analytical Chemistry Department, Faculty of Pharmacy, Cairo University, 11562 Kasr El-Aini St, Cairo, Egypt.
Luminescence. 2021 Aug;36(5):1124-1142. doi: 10.1002/bio.4011. Epub 2021 Apr 16.
Prednisolone acetate (PNO) and fluorometholone (FRT) are corticosteroids, co-formulated with moxifloxacin HCl (MFX) and cromolyn sodium (CML), respectively. PNO has a negligible quantum yield and its hydrolytic degradation products have enhanced fluorescence, which is 250-fold greater. FRT is a nonfluorescent drug, but its hydrolytic degradation products show reasonable fluorescence; MFX and CML have native fluorescence. Two methods were proposed based on the determination of PNO and FRT via their hydrolytic degradation products in the presence of other degradation products. Method (A) was developed for simultaneous determination of PNO and MFX in the presence of PNO degradation products by measuring peak amplitudes of the first derivative ( D) of its enhanced fluorescence; PNO and MFX were measured at 345 and 473 nm, respectively. Method (B) is a synchronous fluorescence spectroscopic method for simultaneous determination of FRT and its co-formulated drug CML in the presence of its degradation products. Fluorescence intensities were measured at λ 283 and 347 nm for FRT and CML, respectively, using Δλ = 99.20 nm. Validation of the proposed methods was conducted as per International Council for Harmonisation (ICH) guidelines. The proposed methods were successfully applied for the determination of the proposed drugs in bulk powder, ophthalmic solution, and rabbit's aqueous humour.
醋酸泼尼松龙(PNO)和氟米龙(FRT)是皮质类固醇,分别与盐酸莫西沙星(MFX)和色甘酸钠(CML)组合。PNO 的量子产率可忽略不计,其水解降解产物的荧光增强了 250 倍。FRT 是一种非荧光药物,但它的水解降解产物显示出合理的荧光;MFX 和 CML 具有天然荧光。提出了两种方法,分别基于在其他降解产物存在下通过其水解降解产物测定 PNO 和 FRT。方法(A)是在 PNO 降解产物存在下同时测定 PNO 和 MFX 的方法,通过测量其增强荧光的一阶导数(D)的峰幅度来实现;PNO 和 MFX 分别在 345nm 和 473nm 处进行测定。方法(B)是一种同步荧光光谱法,用于在其降解产物存在下同时测定 FRT 和其共制剂药物 CML。FRT 和 CML 的荧光强度分别在 283nm 和 347nm 处进行测量,使用 Δλ=99.20nm。根据国际协调理事会(ICH)指南对所提出的方法进行了验证。所提出的方法成功地应用于测定原料药、眼用溶液和兔房水中的提议药物。