Scholarlink

<p>Brinzolamide has been quantified in bulk and pharmaceutical dose form using an analytical quality by design (AqbD)-based instrumental thin-layer chromatography (TLC) approach that is sensitive, accurate, precise, and robust. The Box‒Behnken design was applied to the chromatographic conditions in TLC for better efficiency and reliability. The method used TLC aluminum plates precoated with silica gel 60 F<sub>254</sub> as the stationary phase and toluene‒acetone‒methanol (6.5:2:1.5, <i>V/V</i>) as the mobile phase. The retardation factor (<i>R</i><sub>F</sub>) was recorded as 0.53, indicating the reliability of the chromatographic results. The densitometric analysis was carried out in absorbance mode at a wavelength of 254&#xa0;nm. The independent variables used in the optimization were mobile phase composition, chamber saturation time, and development distance. The linearity was determined to be between 250 and 1500&#xa0;ng/band, with a correlation coefficient (<i>R</i>) of 0.9983. The limit of detection (LOD) and limit of quantification (LOQ) were determined to be 50 and 152&#xa0;ng/band, respectively. The proposed technique was validated in accordance with the International Council for Harmonisation (ICH) guidelines Q2(R1). The proposed approach for forced degradation research was tested on brinzolamide under stress conditions such as acid and base hydrolysis, photolytic, thermal, and oxidative stress degradation to create the stability-indicating method. The statistical study supports the method’s suitability for evaluating brinzolamide in pharmaceutical formulations, with no influence from excipients, as per ICH recommendations.</p>

错误：搜索内容不能为空，请输入英文关键词
错误：关键词超出字数限制，请精简
高级检索

A green stability-indicating instrumental thin-layer chromatography method for the determination of brinzolamide in bulk and its formulations using an analytical quality by design approach

  • 期刊论文

  • 发表日期：

    2026年2月13日

查看全文
  • Hina Bagada,
  • Vaishali Dabhi,
  • Dharmendra Baria,
  • Dinesh Thakkar,
  • Vaishali Karkhanis,
  • Bansari Patel

摘要

Brinzolamide has been quantified in bulk and pharmaceutical dose form using an analytical quality by design (AqbD)-based instrumental thin-layer chromatography (TLC) approach that is sensitive, accurate, precise, and robust. The Box‒Behnken design was applied to the chromatographic conditions in TLC for better efficiency and reliability. The method used TLC aluminum plates precoated with silica gel 60 F254 as the stationary phase and toluene‒acetone‒methanol (6.5:2:1.5, V/V) as the mobile phase. The retardation factor (RF) was recorded as 0.53, indicating the reliability of the chromatographic results. The densitometric analysis was carried out in absorbance mode at a wavelength of 254 nm. The independent variables used in the optimization were mobile phase composition, chamber saturation time, and development distance. The linearity was determined to be between 250 and 1500 ng/band, with a correlation coefficient (R) of 0.9983. The limit of detection (LOD) and limit of quantification (LOQ) were determined to be 50 and 152 ng/band, respectively. The proposed technique was validated in accordance with the International Council for Harmonisation (ICH) guidelines Q2(R1). The proposed approach for forced degradation research was tested on brinzolamide under stress conditions such as acid and base hydrolysis, photolytic, thermal, and oxidative stress degradation to create the stability-indicating method. The statistical study supports the method’s suitability for evaluating brinzolamide in pharmaceutical formulations, with no influence from excipients, as per ICH recommendations.