Department of Studies in Chemistry, University of Mysore, Manasagangotri, Mysore-570006, India.
Acta Pharm. 2010 Jun;60(2):217-27. doi: 10.2478/v10007-010-0015-x.
Spectrophotometric methods are proposed for the determination of drugs containing a phenol group [salbutamol sulphate (SLB), ritodrine hydrochloride (RTD), isoxsuprine hydrochloride (IXP)] and drugs containing an aromatic amine group [dapsone hydrochloride (DAP), sulfamethoxazole (SFM), and sulfadiazine (SFD)] in pharmaceutical dosage forms. The methods are based on coupling of N, N-diethyl-p-phenylenediamine sulphate with the drugs in the presence of KIO4 to give a green colored product (λmax at 670 nm) and a red colored product (λmax at 550 nm), respectively. Linear relationships with good correlation coefficients (0.9986-0.9996) were found between absorbance and the corresponding concentration of drugs in the range 1-7, 2-22, 1-17, 1.5-12, 2-25, and 2-21 μg mL-1 for SLB, RTD, IXP, DAP, SFM and SFD, respectively. Variable parameters such as temperature, reaction time and concentration of the reactants have been analyzed and optimized. The RSD of intra-day and inter-day studies was in the range of 0.2-1.0 and 0.4-1.0%, respectively. No interference was observed from common pharmaceutical adjuvants. The reliability and performance of the proposed methods was validated statistically; the percentage recovery ranged from 99.5 ± 0.1 to 99.9 ± 0.3%. Limits of detection were 0.14, 0.21, 0.51, 0.44, 0.33 and 0.37 μg mL-1 for SLB, RTD, IXP, DAP, SFM, and SFD, respectively.
提出了分光光度法测定含酚基团的药物[硫酸沙丁胺醇(SLB)、盐酸利托君(RTD)、盐酸异舒普林(IXP)]和含芳胺基团的药物[盐酸氨苯砜(DAP)、磺胺甲噁唑(SFM)和磺胺嘧啶(SFD)]在药物制剂中的含量。该方法基于在 KIO4 存在下,N,N-二乙基对苯二胺硫酸盐与药物偶联,分别得到绿色产物(λmax 在 670nm)和红色产物(λmax 在 550nm)。在 1-7、2-22、1-17、1.5-12、2-25 和 2-21μg mL-1 范围内,SLB、RTD、IXP、DAP、SFM 和 SFD 的吸光度与相应药物浓度之间均呈良好的线性关系,相关系数为 0.9986-0.9996。分析并优化了温度、反应时间和反应物浓度等可变参数。日内和日间研究的 RSD 分别在 0.2-1.0 和 0.4-1.0%范围内。常见药物赋形剂无干扰。统计验证了所提出方法的可靠性和性能;回收率在 99.5±0.1%至 99.9±0.3%之间。SLB、RTD、IXP、DAP、SFM 和 SFD 的检测限分别为 0.14、0.21、0.51、0.44、0.33 和 0.37μg mL-1。