Analytical Quality by Design (AQbD) as a multiaddressable platform for co-encapsulating drug assays

Basso, João; Mendes, Maria; Cova, Tânia F.G.G.; Sousa, João; Pais, Alberto A. C. C.

doi:10.1039/c8ay01695j

Cited by 26 publications

(32 citation statements)

References 21 publications

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“…Following our previous knowledge regarding the chromatographic behavior of ATO, CUR and the IS, a binary mixture of acetonitrile and 2% (v/v) acetic acid was initially selected, as it proved to be a rapid and International Conference for Harmonization (ICH) compliant analytical method (Basso, Mendes, et al, ). Yet the translation to biological matrices failed to meet the ICH criteria, owing to the occasional presence of matrix peaks at the retention times of ATO, CUR and/or IS in blank brain and liver samples.…”

Section: Resultsmentioning

confidence: 99%

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Development and full validation of an HPLC methodology to quantify atorvastatin and curcumin after their intranasal co‐delivery to mice

Silva

Sousa

Fortuna

et al. 2019

Biomedical Chromatography

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There is increasing interest in atorvastatin and curcumin owing to their potential anticancer activity. A new, accurate and sensitive HPLC method was developed, for the first time, to simultaneously quantify atorvastatin and curcumin in mouse plasma and brain, liver, lung and spleen tissues following protein precipitation sample preparation. The chromatographic separation was achieved in 13 min on a C 18 column, at 35°C, using a mobile phase composed of acetonitrile-methanol-2% (v/v) acetic acid (37.5:2.5:60, v/v/v) at a flow rate of 1.0 mL/min. The detection of analytes and internal standard was carried out at 247, 425 and 250 nm, respectively. According to international guidelines, the method was shown to be selective, with lower limits of quantification ranging from 10 to 500 ng/mL for curcumin, and from 100 to 600 ng/mL for atorvastatin, linear over a wide concentration range (r 2 ≥ 0.9971) and with acceptable accuracy (bias ± 12.29%) and precision (coefficient of variation ≤13.15%). The analytes were reproducibly recovered at a percentage >81.10% and demonstrated to be stable under various experimental conditions in all biological matrices. This method can be easily applied to in vivo biodistribution studies related to the intranasal administration of atorvastatin and curcumin, separately or simultaneously.

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Section: Resultsmentioning

confidence: 99%

“…Stock solutions were stored at −20°C and protected from light. Under these storage conditions, they are stable for 15 days as previously described (Basso et al, ).…”

Section: Methodsmentioning

confidence: 99%

Development and full validation of an HPLC methodology to quantify atorvastatin and curcumin after their intranasal co‐delivery to mice

Silva

Sousa

Fortuna

et al. 2019

Biomedical Chromatography

Self Cite

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“…Five samples of each concentration level were prepared. The RSD determined at each concentration level should not exceed 15%, except for the lower concentrations, where a maximum of 20% was allowed [20,24].…”

Section: Accuracy and Precisionmentioning

confidence: 99%

“…Five replicates of quality control solutions were prepared to evaluate the stability of IVRT samples at room temperature storage (25 • C) for 24 h in the autosampler and in short-term storage at 4 • C for 72 h [24,25]. The same acceptance criteria established during precision and accuracy assessments were used.…”

Section: Stabilitymentioning

confidence: 99%

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Fast Screening Methods for the Analysis of Topical Drug Products

Miranda

Cardoso²,

Vitorino

2020

Processes

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Considering the recent regulatory requirements, the overall importance of in vitro release testing (IVRT) methods regarding topical product development is undeniable, especially when addressing particulate systems. For each IVRT study, several hundreds of samples are generated. Therefore, developing rapid reversed-phase high-performance liquid chromatography (RP-HPLC) methods, able to provide a real-time drug analysis of IVRT samples, is a priority. In this study, eight topical complex drug products exhibiting distinct physicochemical profiles were considered. RP-HPLC methods were developed and fully validated. Chromatographic separations were achieved on a XBridgeTM C18 (5 µm particle size, 150 mm × 2.1 mm), or alternatively on a LiChrospher® 100 RP-18 (5 µm particle size, 125 mm × 4.6 mm) at 30 °C, under isocratic conditions using UV detection at specific wavelengths. According to the physicochemical characteristics of each drug, different mobile phases were selected. Irrespective of the drug (hydrocortisone, etofenamate, bifonazole, clotrimazole, acyclovir, tioconazole, clobetasol, and diclofenac) and formulation, retention time values did not exceed 6.5 min. All methods were linear, specific, precise, and accurate at the intraday and interday levels, robust, and stable. These were successfully applied to establish product-specific IVRT profiles, thus providing a key database useful for topical pharmaceutical manufacturers.

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Quantitative NMR in Quality Control

Liu

2024

Quality Control of Chinese Medicines

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Analytical Quality by Design (AQbD) as a multiaddressable platform for co-encapsulating drug assays

Abstract: AQbD provided a comprehensive framework for developing a reliable, effective, flexible band robust method for the routine analysis of the compounds in quality control laboratories.

Cited by 26 publications

References 21 publications

Development and full validation of an HPLC methodology to quantify atorvastatin and curcumin after their intranasal co‐delivery to mice

Development and full validation of an HPLC methodology to quantify atorvastatin and curcumin after their intranasal co‐delivery to mice

Fast Screening Methods for the Analysis of Topical Drug Products

Quantitative NMR in Quality Control

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