Application of analytical quality by design (AQbD) for stability-indicating method development for quantification of nevirapine and its degradation products

Jesus do Nascimento Lopes, Ivone de; Kazumasa Fujimori, Sérgio; de Carvalho Mendes, Thamara; Adrielle Dias de Almeida, Rayza; Furtado de Mendonça de Sousa, Flávia; Areias de Oliveira, Camila; Dibo do Nascimento, Diogo; Rebello Lourenço, Felipe; Isabel Rodrigues, Maria; Deris Prado, Livia

doi:10.1016/j.microc.2024.109939

Microchemical Journal

2024

DOI: 10.1016/j.microc.2024.109939

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Application of analytical quality by design (AQbD) for stability-indicating method development for quantification of nevirapine and its degradation products

Ivone de Jesus do Nascimento Lopes,

Sérgio Kazumasa Fujimori,

Thamara de Carvalho Mendes

et al.

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Development of a QAMS Analysis Method for Industrial Lanolin Alcohol Based on the Concept of Analytical Quality by Design

Abudureheman,

Wang,

Zhang

et al. 2024

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The Analytical Quality by Design (AQbD) concept was adopted to establish a quantitative analysis of multi-components with a single marker (QAMS) method for industrial lanolin alcohol, targeting cholesterol, lanosterol, and 24,25-dihydrolanosterol. The potential critical method parameters (CMPs) were identified as column temperature, flow rate, and gradient. Definitive screening design and statistical modeling were employed to optimize the gradient conditions of the mobile phase, column temperature, and flow rate. The Method Operable Design Region (MODR) was determined using a risk-based quantification approach. The robustness was assessed using a Plackett–Burman experimental design, followed by methodological validation. Optimal analytical conditions were as follows: acetonitrile (B)—water (A) mobile phase system; flow rate of 1.58 mL/min; detection wavelength of 205 nm; injection volume of 10 µL; and column temperature of 37 °C. A gradient elution program was implemented as follows: 0–19.0 min, 90.5% B; 19.0–25.0 min, 90.5–100% B; and 25.0–55.0 min, 100% B. Cholesterol served as an internal standard for quantifying lanosterol and 24,25-dihydrolanosterol, with relative correction factors of 0.4227 and 0.8228, respectively. This analytical method utilized only the cholesterol reference substance as an internal standard to quantify the content of cholesterol, lanosterol, and 24,25-dihydrolanosterol in industrial lanolin alcohol. It reduced the testing costs and enhanced efficiency, making it potentially suitable for widespread adoption in lanolin alcohol processing industries.

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Development of a QAMS Analysis Method for Industrial Lanolin Alcohol Based on the Concept of Analytical Quality by Design

Abudureheman,

Wang,

Zhang

et al. 2024

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Application of analytical quality by design (AQbD) for stability-indicating method development for quantification of nevirapine and its degradation products

Cited by 1 publication

References 34 publications

Development of a QAMS Analysis Method for Industrial Lanolin Alcohol Based on the Concept of Analytical Quality by Design

Development of a QAMS Analysis Method for Industrial Lanolin Alcohol Based on the Concept of Analytical Quality by Design

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