An Application of Quality by Design and Analytical Greenness Assessment Approach for the Development of Erlotinib Stability Indicating Method

Gundecha, Satyam; Patel, Mital; Mayur, Y.C.

doi:10.1007/s10337-022-04167-7

Cited by 8 publications

(2 citation statements)

References 38 publications

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“…Pharmaceutical Quality by Design (QbD) is an analytical approach to pharmaceutical method development that is systematic, comprehensive, and risk-based. It focuses on achieving prede ned goals and emphasizes the importance of process control for stability-indicating analytical method development (SIAM) [31], [32]. The term Analytical Quality by Design (AQbD) refers to the development of analytical methods using the quality by design approach [33].…”

Section: Implementation Of Quality By Design Approach For Siam Method...mentioning

confidence: 99%

Advancing Quality and Environmental Responsibility: A Stability-Indicating LC Method Development for Lenvatinib Through QbD and Green Chemistry

Tiwari

Patel

2023

Chromatographia

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A Quality by Design (QbD) technique that was systematic and analytical was utilized to create and con rm a novel and sensitive stability-indicating method of Lenvatinib via the HPLC method. To comply with ICH Q1(A) guidelines, a study was conducted to determine the degradation behavior of Lenvatinib under various environmental conditions. The QbD approach involved screening and optimization, which included using Placket Burman to assess primary parameters, and Response Surface Design (RSD) to optimize critical factors. The degradation was examined under different degradation conditions, including acidic, basic, oxidative, neutral, thermal, and photolytic, and was separated using a Shimadzu® C18 column (250 mm x 4.6 mm, particle size 5 µ). The mobile phase consisted of a concentration of Acetonitrile: 10 mM ammonium acetate having pH 3.5 (39:61, v/v) at a ow rate of 0.8 mL/min, 20 min run time, and 245 nm wavelength. The drug was particularly sensitive towards acidic and basic hydrolysis stress conditions, which generated a total of ve degradant products that were successfully identi ed with the optimized LC-MS compatible analytical method. The optimized method was found to be sensitive, reproducible, speci c, and robust, with a linearity range of 10 to 60 mg/mL and a correlation coe cient (R 2 = 0.9993). The greenness score of the analytical method was calculated, and it was observed that the developed method was environmentally friendly.

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Section: Implementation Of Quality By Design Approach For Siam Method...mentioning

confidence: 99%

Advancing Quality and Environmental Responsibility: A Stability-Indicating LC Method Development for Lenvatinib Through QbD and Green Chemistry

Tiwari

Patel

2023

Chromatographia

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“…In the process of developing new drugs, the AQbD approaches have been applied in several stages, such as raw material control [ 94 ], bioassay [ 95 , 96 ], stability test [ 96 , 97 ], impurity test [ 98 , 99 , 100 ], efficacy and safety test [ 101 ]. However, there are several limits to apply the AQbD approach in developing new drugs based on medicinal plants, and this is closely related to the limitations of botanical resources as a raw material for drug development [ 1 ].…”

Section: Perspectives : Challenges and Prospectsmentioning

confidence: 99%

Analytical Quality by Design (AQbD) Approach to the Development of Analytical Procedures for Medicinal Plants

Park

Kim

et al. 2022

Plants

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Scientific regulatory systems with suitable analytical methods for monitoring quality, safety, and efficacy are essential in medicinal plant drug discovery. There have been only few attempts to adopt the analytical quality by design (AQbD) strategy in medicinal plants analysis over the last few years. AQbD is a holistic method and development approach that understands analytical procedure, from risk assessment to lifecycle management. The enhanced AQbD approach reduces the time and effort necessary to develop reliable analytical methods, leads to flexible change control through the method operable design region (MODR), and lowers the out-of-specification (OOS) results. However, it is difficult to follow all the AQbD workflow steps in the field of medicinal plants analysis, such as defining the analytical target profiles (ATPs), identifying critical analytical procedure parameters (CAPPs), among others, because the complexity of chemical and biological properties in medicinal plants acts as a barrier. In this review, various applications of AQbD to medicinal plant analytical procedures are discussed. Unlike the analysis of a single compound, medicinal plant analysis is characterized by analyzing multiple components contained in biological materials, so it will be summarized by focusing on the following points: Analytical methods showing correlations within analysis parameters for the specific medicinal plant analysis, plant raw material diversity, one or more analysis targets defined for multiple phytochemicals, key analysis attributes, and analysis control strategies. In addition, the opportunities available through the use of design-based quality management techniques and the challenges that coexist are also discussed.

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Novel RP‐HPLC method for estimation of a newly developed combination of tizanidine and etoricoxib in rat plasma: Eight criteria for greens evaluation

Assirey,

Ahmed,

AL‐Faze

et al. 2024

Archiv der Pharmazie

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A novel environmentally friendly reversed‐phase high‐performance liquid chromatography (RP‐HPLC) method has been effectively validated for simultaneously measuring a prospective conjunction of tizanidine (TIZ) and etoricoxib (ETC), the combined medicine, in rat plasma. The technique employs diclofenac potassium as the internal standard, guaranteeing dependable and precise outcomes. This study aimed to assess the impact of the suggested combination therapy on treating inflammation resulting from rheumatoid arthritis (RA) in a rat model. The procedure was performed using an Agilent series 1200 model HPLC apparatus. The chromatographic conditions consist of isocratic elution mode, C18 column with dimensions of 150 mm × 4.6 mm × 5 µm, flow rate of 1.5 mL/min, wavelength of 230 nm, temperature of 50°C, and injection volume of 10 µL. The elution was performed using a mobile phase consisting of a phosphate buffer with a pH of 3.5 and acetonitrile in a ratio of 80:20 v/v. Calibration curves were conducted for TIZ and ETC within the 1–50 µg/mL range, demonstrating linear trends with R2 values over 0.999. The effectiveness and eco‐friendliness of the proposed method were evaluated using eight separate environmentally conscious metrics. The addition of TIZ and ETC to arthritic rodents amplified these effects significantly. Furthermore, TIZ and ETC significantly reduced serum levels in arthritic rodents, and safety investigations revealed normal complete blood count, liver, and renal functions. TIZ and ETC appear to have antiarthritic, anti‐inflammatory, and safe combinations, making them viable future treatment options for RA that are also safe and efficacious. Following validation by United States Food and Drug Administration (US‐FDA) rules, all goods met the criteria.

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An Application of Quality by Design and Analytical Greenness Assessment Approach for the Development of Erlotinib Stability Indicating Method

Cited by 8 publications

References 38 publications

Advancing Quality and Environmental Responsibility: A Stability-Indicating LC Method Development for Lenvatinib Through QbD and Green Chemistry

Advancing Quality and Environmental Responsibility: A Stability-Indicating LC Method Development for Lenvatinib Through QbD and Green Chemistry

Analytical Quality by Design (AQbD) Approach to the Development of Analytical Procedures for Medicinal Plants

Novel RP‐HPLC method for estimation of a newly developed combination of tizanidine and etoricoxib in rat plasma: Eight criteria for greens evaluation

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