Kamal Amira H, Hammad Sherin F, Kamel Doaa N
Department of Pharmaceutical Analytical Chemistry, Faculty of Pharmacy, Tanta University, Tanta, Egypt.
Department of Pharmaceutical Analytical Chemistry, Faculty of Pharmacy, Tanta University, Tanta, Egypt.
Spectrochim Acta A Mol Biomol Spectrosc. 2021 Jun 5;254:119641. doi: 10.1016/j.saa.2021.119641. Epub 2021 Feb 27.
Two simple chemometric spectrophotometric methods; isosbestic point and dual wavelength methods were developed, validated and applied to the determination of metoprolol succinate in presence of amlodipine besylate in their binary mixtures and in combined tablet formulation while amlodipine besylate was determined by direct spectrophotometry at λ = 365 nm within linearity range of 2-25 μg/mL. The mean percentage recovery ± SD was 99.921 ± 0.089 for amlodipine besylate. Two proposed chemometric spectrophotometric methods were developed for the spectral resolution of metoprolol succinate in presence of amlodipine besylate without preliminary separation with a linearity range of 2-30 μg/mL metoprolol succinate. The first method depended on measuring the absorbance at the isosbestic point at λ = 226 nm. The mean percentage recovery ± SD was 100.110 ± 0.249 for metoprolol succinate. The second method was dual wavelength method, metoprolol could be determined alone using the absorbance difference between 226 nm and 248.7 nm where the absorbance difference was zero for amlodipine at these two wavelengths. The mean percentage recovery ± SD was 99.734 ± 0.438 for metoprolol succinate using dual wavelength method. The developed methods were validated as per ICH guidelines and were successfully applied to analysis of cited drugs in their synthetic tablet formulation. The results obtained by the developed methods were statistically compared to those obtained by a reported one using t-test and F- test. Good agreement was observed.
开发、验证了两种简单的化学计量学分光光度法,即等吸收点法和双波长法,并将其应用于测定二元混合物及复方片剂中琥珀酸美托洛尔在苯磺酸氨氯地平存在下的含量,而苯磺酸氨氯地平通过在λ = 365 nm处直接分光光度法在2 - 25 μg/mL线性范围内进行测定。苯磺酸氨氯地平的平均回收率±标准差为99.921 ± 0.089。针对在苯磺酸氨氯地平存在下的琥珀酸美托洛尔,开发了两种化学计量学分光光度法用于光谱解析,无需预先分离,琥珀酸美托洛尔的线性范围为2 - 30 μg/mL。第一种方法是在λ = 226 nm的等吸收点处测量吸光度。琥珀酸美托洛尔的平均回收率±标准差为100.110 ± 0.249。第二种方法是双波长法,可利用226 nm和248.7 nm处的吸光度差值单独测定美托洛尔,在此两个波长下苯磺酸氨氯地平的吸光度差值为零。使用双波长法测定琥珀酸美托洛尔时,平均回收率±标准差为99.734 ± 0.438。所开发的方法按照国际协调会议(ICH)指南进行了验证,并成功应用于所引用药物的合成片剂配方分析。通过t检验和F检验,将所开发方法得到的结果与报道方法得到的结果进行了统计学比较。观察到良好的一致性。