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采用绿色反相高效薄层色谱法和常规正相高效薄层色谱法对剂型中的恩曲他滨进行定量分析——验证参数对比

Quantitative Analysis of Emtricitabine in Dosage Forms Using Green RP-HPTLC and Routine NP-HPTLC Methods-A Contrast of Validation Parameters.

作者信息

Alam Prawez, Haq Nazrul, Alqarni Mohammed H, Shakeel Faiyaz

机构信息

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

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

出版信息

ACS Omega. 2020 Dec 18;5(51):33470-33477. doi: 10.1021/acsomega.0c05537. eCollection 2020 Dec 29.

Abstract

In this research, an antiviral drug emtricitabine (ECT) was quantified using the validated green reversed-phase high-performance thin-layer chromatography (RP-HPTLC) and routine normal-phase HPTLC (NP-HPTLC) methods in the marketed oral solutions and capsules. Green RP-HPTLC-densitometry quantification was performed using the acetone/water (70:30, v/v) solvent system as the mobile phase. Routine NP-HPTLC-densitometry quantification was performed using the chloroform/methanol (85:15, v/v) solvent system as the mobile phase. The detection was performed at λ-285 nm for both of the methods. Both densitometry methods were validated for different parameters. Most of the validation parameters including linearity, precision, accuracy, detection, and quantification limits for the green densitometry method were found to be superior compared to the routine densitometry technique. The ECT contents of commercial oral solution and commercial capsules were found to be 100.85 and 98.27%, respectively, using the green densitometry technique. The ECT contents of oral solutions and capsules were 97.16 and 95.54%, respectively, using the routine densitometry technique. Accordingly, the green densitometry technique was found to be better than the routine densitometry technique for ECT assays. Thus, the green densitometry technique can be successfully applied for the quantitation of ECT in the marketed formulations.

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)和常规正相高效薄层色谱法(NP-HPTLC)对市售口服溶液剂和胶囊剂中的抗病毒药物恩曲他滨(ECT)进行定量分析。绿色RP-HPTLC密度测定法定量分析采用丙酮/水(70:30,v/v)溶剂系统作为流动相。常规NP-HPTLC密度测定法定量分析采用氯仿/甲醇(85:15,v/v)溶剂系统作为流动相。两种方法均在λ-285nm波长处进行检测。两种密度测定法均针对不同参数进行了验证。结果发现,绿色密度测定法的大多数验证参数,包括线性、精密度、准确度、检测限和定量限,均优于常规密度测定技术。采用绿色密度测定技术,市售口服溶液剂和市售胶囊剂中ECT的含量分别为100.85%和98.27%。采用常规密度测定技术,口服溶液剂和胶囊剂中ECT的含量分别为97.16%和95.54%。因此,对于ECT含量测定,绿色密度测定技术优于常规密度测定技术。因此,绿色密度测定技术可成功应用于市售制剂中ECT的定量分析。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/8598/7774264/13183ff49da6/ao0c05537_0002.jpg

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