Lotfy Hayam Mahmoud, Ahmed Dina Abbas, Abdel Rahman Mohamed Khaled, Weshahy Soheir Abdel Fattah
Analytical Chemistry Department, Faculty of Pharmacy, Cairo University, Kasr El- Aini Street, 11562 Cairo, Egypt.
Pharmaceutical Chemistry Department, Faculty of Pharmaceutical Science and Pharmaceutical Industries, Future University in Egypt, 5th Settlement, 11835 Cairo, Egypt.
Heliyon. 2019 May 9;5(5):e01669. doi: 10.1016/j.heliyon.2019.e01669. eCollection 2019 May.
Six simple, sensitive and selective spectrophotometric methods based on mathematical filtration technique are presented for concurrent determination of aceclofenac (ACE) and paracetamol (PAR) in presence of their degradation products, namely; diclofenac sodium (DIC) and 4-aminophenol (4-AP), respectively without preliminary physical separation procedures. This technique consists of several consecutive steps applied on built-in spectrophotometer software utilizing zero and/or derivative and/or ratio spectra of the studied components. These methods, namely, dual wavelength (DW), induced dual wavelength (IDW), derivative subtraction (DS) coupled with constant multiplication (CM), ratio difference method (RD), constant center method (CC) and the novel introduced unlimited derivative ratio method (UDD). This novel method has a very powerful competence for the analysis of the challengeable mixtures lacking zero crossing point. The linearity, accuracy and precision ranges of these methods were determined and validated as per ICH guidelines. Moreover, the specificity was checked by analyzing synthetic mixtures of both drugs. These methods were applied for the determination of the cited drugs in pharmaceutical formulation and a statistical comparison of the obtained results was made with each other and with those of reported spectrophotometric method. The comparison of the results of pure powder form showed that there is no significant difference between the proposed methods and the reported method regarding both accuracy and precision.
提出了六种基于数学过滤技术的简单、灵敏且选择性好的分光光度法,用于在存在降解产物双氯芬酸钠(DIC)和4-氨基酚(4-AP)的情况下同时测定醋氯芬酸(ACE)和对乙酰氨基酚(PAR),无需预先进行物理分离步骤。该技术由在内置分光光度计软件上应用的几个连续步骤组成,利用所研究组分的零和/或导数和/或比率光谱。这些方法分别为双波长(DW)法、诱导双波长(IDW)法、导数减法(DS)结合常数乘法(CM)法、比率差值法(RD)、常数中心法(CC)以及新引入的无限导数比率法(UDD)。这种新方法对于分析缺乏零交叉点的具有挑战性的混合物具有非常强大的能力。按照国际协调会议(ICH)指南确定并验证了这些方法的线性、准确度和精密度范围。此外,通过分析两种药物的合成混合物来检查特异性。这些方法用于测定药物制剂中所述药物,并对所得结果相互之间以及与报道的分光光度法结果进行了统计比较。纯粉末形式结果的比较表明,所提出的方法与报道的方法在准确度和精密度方面均无显著差异。