AQbD集成了高效薄层色谱法,用于在其降解物和纳米结构脂质载体基质存在的情况下定量估计他伐波罗。

IF 2.4 4区 医学 Q3 CHEMISTRY, MEDICINAL
Rashmin Patel, Savaliya Neel, Patel Mrunali, Yash Patel, Richa Dave, Agrawal Vikas
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引用次数: 0

摘要

背景:Tavaborole (TAV)是一种苯并oxaborole衍生物,是fda批准的用于治疗甲真菌病的抗真菌药物,甲真菌病是一种常见的持续性脚趾甲真菌感染。目的:本研究旨在建立一种可靠的稳定性指示HPTLC方法,通过包括风险评估和分析质量设计的综合方法来测定纳米结构脂质载体(NLC)中的TAV。方法:采用Placket-Burman筛选法对影响hplc结果的关键参数进行筛选,并采用中心复合优化设计对其进行优化。所开发的方法按照ICH建议进行了验证。结果:优化后的方法采用预涂铝背HPTLC板,进样量为10µL/带,以甲苯:乙酸乙酯:甲酸(75:25:1%v/v/v)为等压流动相,在双槽腔中预饱和20 min,流动相为10 mL。分离得到的组分在221nm波长下检测。该方法对TAV的阻滞因子为0.49±0.04。验证结果表明,该方法的特异性(峰纯度≥0.999)、线性范围(2 ~ 10 μg/波段)、灵敏度(LOD 0.209 μg、LOQ 0.635 μg)、准确度(99.68 ~ 101.43%w/w)、精密度(%RSD < 2.0)。结论:建立的高效液相色谱法可用于TAV在NLC制剂中的可持续性测试和稳定性测试。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
AQbD integrated high-performance thin layer chromatographic method for quantitative estimation of Tavaborole in the presence of its degradants and the matrix of nanostructured lipid carriers.

Background: Tavaborole (TAV), a benzoxaborole derivative, is an FDA-approved antifungal agent for treating onychomycosis, a common and persistent fungal infection of the toenails.

Objective: This study aimed to develop a robust stability-indicating HPTLC method to determine TAV in nanostructured lipid carriers (NLC) using a comprehensive approach that includes risk assessment, and Analytical Quality by Design.

Methods: The critical method parameters influencing the HPTLC results were screened using a Plackett-Burman screening design followed by its optimization using a central composite optimization design. The developed method was validated as per ICH recommendation.

Results: Optimized method utilized pre-coated aluminum-backed HPTLC plates using 10 µL/band injection volume, and the plate was developed using an isocratic mobile phase consisting of toluene: ethyl acetate: formic acid (75:25:1%v/v/v) in twin trough chamber pre-saturated for 20 mins with vapors of 10 mL of mobile phase. The separated components were detected at a wavelength of 221 nm. The developed HPTLC method resulted in a retardation factor of 0.49 ± 0.04 for TAV. Validation results revealed the HPTLC method's specificity (peak purity ≥ 0.999), linearity over a concentration range of 2-10 μg/band, sensitivity (LOD 0.21 μg and LOQ 0.64 μg), accuracy (99.68 - 101.43%w/w), and precision (%RSD < 2.0).

Conclusion: The developed robust stability-indicating HPTLC method was successfully implemented for the sustainable testing of the TAV in the NLC formulations and stability testing.

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来源期刊
CiteScore
6.80
自引率
0.00%
发文量
82
审稿时长
4.5 months
期刊介绍: The aim of Drug Development and Industrial Pharmacy is to publish novel, original, peer-reviewed research manuscripts within relevant topics and research methods related to pharmaceutical research and development, and industrial pharmacy. Research papers must be hypothesis driven and emphasize innovative breakthrough topics in pharmaceutics and drug delivery. The journal will also consider timely critical review papers.
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