A comprehensive review on QbD driven analytical procedures developed for the analysis of various drugs

Susmitha, Aggarapu; Rajitha, Galla; Eri, Gireesh Kumar

doi:10.1080/10826076.2023.2204238

Cited by 5 publications

(1 citation statement)

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“…[16][17][18] QbD contributes to the enhancement of method performance, the improvement of overall quality, and the support of the development of products that are both safe and effective in the industry. [18][19][20] Peak purity is very significant in stability indicating chromatographic approach. The presence of degradants in the drug material has a significant impact on its quality and purity.…”

Section: Introductionmentioning

confidence: 99%

Estimation of Lexisinatide in Bulk and Tablets by RP‐UPLC Method Developed by Quality by Design Concept

Godela,

Venugopal,

Yagnambhatla

et al. 2024

Macromolecular Symposia

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The primary goal of the proposed study is to establish and validate a low‐cost, sensitive, reliable, and trouble‐free RP‐UPLC process with improved performance for the direct estimation of Lixisenatide in pure powder and fixed‐dose tablet form. The proposed method is optimized by implementing quality by design studies. The method is optimized using quadratic model of central composite design (CCD) of randomized response surface study. Successful separation of Lixisenatide is obtained by the use of Phenyl‐XBD (1.7 µm, 2.1 mm × 100 mm) column and a mobile phase of acetonitrile: 0.1% w/v OPA (60:40) with 0.5 mL min−1 flow rate. The separated Lixisenatide and its degradants are explorated with PDA detector which has the ability to provide comprehensive spectral information, rapid data acquisition, quantitative analysis, and peak purity analysis of all compounds simultaneously. The RT of Lixisenatide is found to be 1.34 min. The lowest concentration of Lixisenatide's limit of detection and limit of quantification makes guarantees regarding the method's sensitivity. For the provided range of linear concentrations (1.25–7.5 µg mL−1), the regression coefficient is found to be 0.999. The computed average percentage recoveries of Lixisenatide in spiked solutions ranged from 98.9% to 101.2%. The % degradation of Lixisenatide in the presence of a variety of forced conditions confirms the existing method's stability. Lixisenatide is significantly photo sensitive when compared to other stressful conditions such as acid, base hydrolysis, and oxidation. The proposed UPLC approach separates Lixisenatide with high sensitivity, a short retention time, and an affordable solvent system.

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