Application of Plackett-Burman and central composite designs for screening and optimization of factor influencing the chromatographic conditions of HPTLC method for quantification of efonidipine hydrochloride
Application of Plackett-Burman and central composite designs for screening and optimization of factor influencing the chromatographic conditions of HPTLC method for quantification of efonidipine hydrochloride
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DOI：
10.1186/s40543-020-00246-2
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发表时间：
2020-11-05
影响因子：
2.4
通讯作者：
Shirkhedkar, Atul A.
中科院分区：
文献类型：
--
作者：
Chaudhari, Suraj R.;Shirkhedkar, Atul A.
我们在这里报告的分析方法，快速估计盐酸依非地平片剂的统计筛选和优化设计，使用NP-HPTLC。采用薄层色谱法，硅胶60 F-254铝板，乙酸乙酯：二氯甲烷：三乙胺（3：2：0.5v/v）分离盐酸依福地平。盐酸依非地平的Rf值为0.35 ± 0.25，在251 nm处进行定量评价。采用Plackett-Burman和面心中心复合设计（CCD），获得了盐酸依福地平峰面积最大、分离度最好、保留因子足够的紧凑条带。采用Plackett-Burman二水平六变量设计筛选影响反应的显著因素。通过面心CCD选择并优化了突出因素。从面心CCD获得的结果表明，大部分峰面积可在显影距离为8.50 cm和腔室饱和度为17 min时获得。此外，已根据ICH指导原则对当前NP-HPTLC研究的准确度、精密度、灵敏度、耐用性、耐用性和专属性进行了验证。该方法的检出限和定量限分别为10.41 ng和31.57 ng，表明该方法可以准确、精密地检测到纳克级的待测物。目前的NP-HPTLC研究是耐用的，准确的，高灵敏度，可用于盐酸依非地平的常规分析。
We report here an analytical method for expeditious estimation of efonidipine hydrochloride in tablet formulation with statistical screening and optimization designs using NP-HPTLC. TLC silica gel 60 F-254 aluminum plates and ethyl acetate to dichloromethane to triethylamine (3:2:0.5 v/v) were chosen for chromatographic separation of efonidipine hydrochloride. The R-f value for efonidipine hydrochloride turned out to be 0.35 +/- 0.25 and quantitative evaluation was done at 251 nm. Plackett-Burman and face-centered central composite design (CCD) were used to obtain the most peak area and well-resolved compact band with an adequate retention factor of efonidipine hydrochloride. Plackett-Burman design at two-level with six independent variables has been employed for screening of prominent factors that affect the responses. The prominent factors have been selected and are optimized through face-centered CCD. The results obtained from face-centered CCD showed that most peak area can be obtained with development distance 8.50 cm and chamber saturation 17 min. Furthermore, the current NP-HPTLC investigation has been validated according to the ICH guidelines for accuracy, precision, sensitivity, robustness, ruggedness, and specificity. The detection and quantification limit was found that 10.41 ng and 31.57 ng, suggesting that the analysis could be accurately and precisely detected the analyte up to nanogram quantity. The current NP-HPTLC investigation is rugged, accurate, and highly sensitive and could be used for routine analysis of efonidipine hydrochloride.