Khoshneviszadeh Rabea, Fazly Bazzaz Bibi Sedigheh, Housaindokht Mohammad Reza, Ebrahim-Habibi Azadeh, Rajabi Omid
Department of Biology, Science and Research Branch, Islamic Azad University, Tehran, Iran.
Biotechnology Research Center, Drug and Food Control Department, School of Pharmacy, Mashhad University of Medical Sciences, Mashhad, Iran.
Iran J Pharm Res. 2015 Spring;14(2):473-8.
The method has been developed and validated for the determination of hydroquinone in liposomal formulation. The samples were dissolved in methanol and evaluated in 293 nm. The validation parameters such as linearity, accuracy, precision, specificity, limit of detection (LOD) and limit of quantitation (LOQ) were determined. The calibration curve was linear in 1-50 µg/mL range of hydroquinone analyte with a regression coefficient of 0.9998. This study showed that the liposomal hydroquinone composed of phospholipid (7.8 %), cholesterol (1.5 %), alpha ketopherol (0.17 %) and hydroquinone (0.5 %) did not absorb wavelength of 293 nm if it diluted 500 times by methanol. The concentration of hydroquinone reached 10 µg/mL after 500 times of dilution. Furthermore, various validation parameters as per ICH Q2B guideline were tested and found accordingly. The recovery percentages of liposomal hydroquinone were found 102 ± 0.8, 99 ± 0.2 and 98 ± 0.4 for 80%, 100% and 120% respectively. The relative standard deviation values of inter and intra-day precisions were <%2. LOD and LOQ were 0.24 and 0.72 µg/mL respectively.
该方法已被开发并验证用于测定脂质体制剂中的对苯二酚。样品用甲醇溶解，并在293nm处进行评估。测定了线性、准确度、精密度、特异性、检测限（LOD）和定量限（LOQ）等验证参数。对苯二酚分析物在1-50μg/mL范围内校准曲线呈线性，回归系数为0.9998。本研究表明，由磷脂（7.8%）、胆固醇（1.5%）、α-生育酚（0.17%）和对苯二酚（0.5%）组成的脂质体对苯二酚用甲醇稀释500倍后不吸收293nm波长。稀释500倍后对苯二酚浓度达到10μg/mL。此外，按照ICH Q2B指南测试了各种验证参数，并相应得出结果。脂质体对苯二酚的回收率分别为80%、100%和120%时，分别为102±0.8、99±0.2和98±0.4。日内和日间精密度的相对标准偏差值均小于2%。检测限和定量限分别为0.24和0.72μg/mL。
