Pharmaceutical Analytical Chemistry Department, Faculty of Pharmacy, Beni-Suef University, Alshaheed Shehata Ahmad Hegazy St., 62514 Beni-Suef, Egypt.
Spectrochim Acta A Mol Biomol Spectrosc. 2020 Jun 5;233:118213. doi: 10.1016/j.saa.2020.118213. Epub 2020 Mar 4.
Two new smart spectrophotometric methods are developed and validated for the determination of the quatertnary mixture of paracetamol (acetaminophen), diphenhydramine, p-aminophenol, and N-oxide degradate of diphenhydramine. Method A is the novel triple divisor ratio difference method, where the triple divisor ratio spectrum of the component of interest shows a significant amplitude difference at two selected wavelengths where the three interfering substances are used as triple divisor and give constant amplitude all over the spectrum. The triple divisors are normalized spectra of tertiary mixtures containing 40 μg/mL of each of the 3 interfering components. The selected wavelengths are 256-290 nm, 220-230 nm, 230-245 nm and 275-260 nm for the 4 components, respectively. Method B is double divisor - ratio difference-dual wavelength, where the double divisor ratio spectrum of the component of interest shows a significant amplitude difference at two selected wavelengths where two interfering substances are used as double divisor and give constant amplitude all over the spectrum, while the third one shows zero amplitude difference at these two selected wavelengths. The double divisors used are normalized spectra of diphenhydramine /N-oxide degradate of diphenhydramine binary mixture for both paracetamol and p-aminophenol and paracetamol/p-aminophenol binary mixture for both diphenhydramine hydrochloride and its N-oxide degradate. The double divisors binary mixtures contain 40 μg/mL of each component. The selected wavelengths are 243-233 nm, 223.8-270.2 nm, 237-250 nm and 265-234.6 nm for the 4 compounds, respectively. Both methods were successfully applied for the quantification of the four components in laboratory prepared quaternary mixtures and for the quantification of paracetamol and diphenhydramine hydrochloride in panadol night® tablets. The results obtained by the developed methods were compared with those obtained by the United State Pharmacopeial method for the analysis of paracetamol and diphenhydramine, where no significant differences were found.
两种新的智能分光光度法被开发并验证用于测定对乙酰氨基酚(扑热息痛)、苯海拉明、对氨基酚和苯海拉明 N-氧化物降解物的四元混合物。方法 A 是新的三重除数比值差法,其中关注的成分的三重除数比值光谱在两个选定的波长处显示出显著的幅度差,其中三个干扰物质用作三重除数,并在整个光谱中给出恒定的幅度。三重除数是含有 40μg/mL 每种 3 种干扰成分的三元混合物的归一化光谱。所选波长分别为 256-290nm、220-230nm、230-245nm 和 275-260nm,用于 4 种成分。方法 B 是双除数-比值差-双波长法,其中关注的成分的双除数比值光谱在两个选定的波长处显示出显著的幅度差,其中两个干扰物质用作双除数,并在整个光谱中给出恒定的幅度,而第三个在这两个选定的波长处显示出零幅度差。所使用的双除数是苯海拉明/N-氧化物降解物二元混合物的归一化光谱,用于对乙酰氨基酚和对氨基酚以及盐酸苯海拉明和其 N-氧化物降解物的二元混合物,对于对乙酰氨基酚和对氨基酚的双除数二元混合物分别含有 40μg/mL 的每个成分。所选波长分别为 243-233nm、223.8-270.2nm、237-250nm 和 265-234.6nm,用于 4 种化合物。这两种方法都成功地应用于实验室制备的四元混合物中四种成分的定量分析,以及扑热息痛夜片®中对乙酰氨基酚和盐酸苯海拉明的定量分析。所开发方法得到的结果与美国药典方法分析对乙酰氨基酚和苯海拉明得到的结果进行了比较,没有发现显著差异。