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采用绿色反相高效薄层色谱法和正相高效薄层色谱法测定药物制剂中的德拉氟沙星:一项对比研究

Determination of Delafloxacin in Pharmaceutical Formulations Using a Green RP-HPTLC and NP-HPTLC Methods: A Comparative Study.

作者信息

Alam Prawez, Ezzeldin Essam, Iqbal Muzaffar, Mostafa Gamal A E, Anwer Md Khalid, Alqarni Mohammed H, Foudah Ahmed I, Shakeel Faiyaz

机构信息

Department of Pharmacognosy, College of Pharmacy, Prince Sattam Bin Abdulaziz University, Al-Kharj 11942, Saudi Arabia.

Department of Pharmaceutical Chemistry, College of Pharmacy, King Saud University, Riyadh 11451, Saudi Arabia.

出版信息

Antibiotics (Basel). 2020 Jun 25;9(6):359. doi: 10.3390/antibiotics9060359.

Abstract

In this work; delafloxacin (DLFX) was determined using a validated green RP-HPTLC and NP-HPTLC methods in commercial tablets and in-house developed solid lipid nanoparticles (SLNs). RP-HPTLC determination of DLFX was performed using "RP-18 silica gel 60 F254S HPTLC plates". However; NP-HPTLC estimation of DLFX was performed using "silica gel 60 F254S HPTLC plates". For a green RP-HPTLC method; the ternary combination of ethanol:water:ammonia solution (5:4:2 //) was used as green mobile phase. However; for NP-HPTLC method; the ternary mixture of ethyl acetate: methanol: ammonia solution (5:4:2 //) was used as normal mobile phase. The analysis of DLFX was conducted in absorbance/reflectance mode of densitometry at = 295 nm for both methods. RP-HPTLC method was found more accurate, precise, robust and sensitive for the analysis of DLFX compared with the NP-HPTLC method. The % assay of DLFX in commercial tablets and in-house developed SLNs was determined as 98.2 and 101.0%, respectively, using the green RP-HPTLC technique, however; the % assay of DLFX in commercial tablets and in-house developed SLNs was found to be 94.4 and 95.0%, respectively, using the NP-HPTLC method. Overall, the green RP-HPTLC method was found superior over the NP-HPTLC. Therefore, the proposed green RP-HPTLC method can be successfully applied for analysis of DLFX in commercial tablets, SLNs and other formulations containing DLFX.

摘要

在本研究中,采用经过验证的绿色反相高效薄层色谱法(RP-HPTLC)和正相高效薄层色谱法(NP-HPTLC)测定了市售片剂和自行研制的固体脂质纳米粒(SLN)中的德拉氟沙星(DLFX)。使用“RP-18硅胶60 F254S HPTLC板”进行DLFX的RP-HPTLC测定。然而,使用“硅胶60 F254S HPTLC板”进行DLFX的NP-HPTLC测定。对于绿色RP-HPTLC法,乙醇:水:氨溶液(5:4:2 //)的三元组合用作绿色流动相。然而,对于NP-HPTLC法,乙酸乙酯:甲醇:氨溶液(5:4:2 //)的三元混合物用作常规流动相。两种方法均在295 nm的吸光度/反射率模式下进行光密度测定以分析DLFX。与NP-HPTLC法相比,发现RP-HPTLC法对DLFX的分析更准确、精密、稳健且灵敏。使用绿色RP-HPTLC技术测定市售片剂和自行研制的SLN中DLFX的含量分别为98.2%和101.0%,然而,使用NP-HPTLC法测定市售片剂和自行研制的SLN中DLFX的含量分别为94.4%和95.0%。总体而言,发现绿色RP-HPTLC法优于NP-HPTLC法。因此,所提出的绿色RP-HPTLC法可成功应用于分析市售片剂、SLN及其他含DLFX的制剂中的DLFX。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/5075/7344820/ecbbcdbad496/antibiotics-09-00359-g001.jpg

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