Department of Pharmaceutical Analytical Chemistry, Faculty of Pharmacy, Tanta University, The Medical Campus of Tanta University, Elgeish Street, Tanta, Egypt.
Luminescence. 2021 May;36(3):733-741. doi: 10.1002/bio.3996. Epub 2021 Jan 10.
Two simple and sensitive spectrofluorimetric methods were developed and validated for determination of diphenhydramine. The use of sodium dodecyl sulfate surfactant at pH 7 enhances the fluorescence intensity of diphenhydramine at 286 nm (method I) enabling its nanodetermination in biological samples with mean per cent recovery ± SD of 100.33 ± 1.519. Method I was validated according to ICH-Q2R1 guidelines and was successfully applied for determination of diphenhydramine in pharmaceutical dosage form and spiked human plasma in the concentration ranges 0.1-4.0 μg/mL and 0.2-1.0 μg/mL, respectively. Method I acted as a basis for the development of a first derivative synchronous spectrofluorimetry (method II) for simultaneous analysis of diphenhydramine and naproxen using a zero-crossing approach. Method II determines both drugs with linearity ranges of 0.05-3.0 μg/mL and 0.1-0.9 μg/mL for diphenhydramine and naproxen, respectively. The developed method was applied for the simultaneous determination of both drugs in their laboratory-prepared mixtures containing all expected excipients. Method II determines both drugs with a mean percent recovery ± SD of 100.56 ± 0.891 and 100.20 ± 1.125 for diphenhydramine and naproxen, respectively. The method was statistically compared with a reported method using Student's t- and F- tests, and no significant differences were observed.
两种简单灵敏的分光荧光法被开发并验证用于测定苯海拉明。在 pH 7 下使用十二烷基硫酸钠表面活性剂增强了苯海拉明在 286nm 处的荧光强度（方法 I），使其能够在生物样品中进行纳级测定，平均回收率的均值 ± SD 为 100.33 ± 1.519。方法 I 根据 ICH-Q2R1 指南进行了验证，并成功应用于测定药物制剂和加标人血浆中的苯海拉明，浓度范围分别为 0.1-4.0μg/mL 和 0.2-1.0μg/mL。方法 I 为建立第一衍生物同步分光荧光法（方法 II）奠定了基础，该方法可使用零交叉法同时分析苯海拉明和萘普生。方法 II 对苯海拉明和萘普生的线性范围分别为 0.05-3.0μg/mL 和 0.1-0.9μg/mL。所开发的方法应用于其含有所有预期赋形剂的实验室制备混合物中两种药物的同时测定。方法 II 测定两种药物的平均回收率 ± SD 分别为 100.56 ± 0.891 和 100.20 ± 1.125。该方法与已报道的方法进行了统计学比较，采用了学生 t 检验和 F 检验，未观察到显著差异。
