A Quality by Design (QbD) approach to the development of a gradient high-performance liquid chromatography for the simultaneous assay of curcuminoids and doxorubicin from long-circulating liposomes

Sylvester, Bianca; Tefas, Lucia Ruxandra; Vlase, Laurian; Tomuță, Ioan; Porfire, Alina

doi:10.1016/j.jpba.2018.06.018

Cited by 35 publications

(13 citation statements)

References 36 publications

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“…For designing the ATP, the necessary characteristics that are considered to be the indicators of method performance were determined. 15 The CQA's were defined from ATP to identify satisfactory performance of the developed method and to give reliable results.…”

Section: Defining Of Analytical Target Profile (Atp) and Critical Quamentioning

confidence: 99%

Standardization of Trigonella foenum-graecum L. Seeds: A Quality by Design Approach

Gaonkar¹,

Hullatti²,

Mannur³

2020

IJPER

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Section: Defining Of Analytical Target Profile (Atp) and Critical Quamentioning

confidence: 99%

Standardization of Trigonella foenum-graecum L. Seeds: A Quality by Design Approach

Gaonkar¹,

Hullatti²,

Mannur³

2020

IJPER

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“…Through QbD, Sylvester et al [49] developed an HPLC method for the simultaneous determination of curcuminoids and doxorubicin from long-circulating liposomes. The authors established a MODR by means of a DoE and RSM.…”

Section: Quality By Design (Qbd) Design Of Space and Design Of Expermentioning

confidence: 99%

Key information related to quality by design (QbD) applications in analytical methods development

Araujo¹,

Andrade²,

Babos³

et al. 2020

Braz. J. Anal. Chem.

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In this review, quality by design (QbD) initiatives are described as applications for many types of processes, such as in the pharmaceutical industry, biotechnology field, and for analytical methods development. Design space (DS) and design of experiments (DoE) provide useful results for analytical methods development and simulation of advanced processes in traditional manufacturing relationships. The three topics, QbD, DS and DoE are the best way to achieve strong and efficient industrial production.

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“…The QbD for analytical method development provides an option for continual improvement of method performance throughout the method life-cycle. For the past 5 years, scientifically justified and systematically optimized methods using QbD vouches for its suitability for various analytical purposes [10][11][12][13][14]. Hence, the authors combined the AES approach with QbD to develop a green analytical method to produce sustainable, robust method performance.…”

Section: Introductionmentioning

confidence: 99%

Analytical eco‐scale and quality by design‐oriented liquid chromatography method for simultaneous quantification of metoprolol succinate, telmisartan, and cilnidipine in their fixed‐dose combination

Panda

Dutta

Bera

et al. 2021

Separation Science Plus

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A new combination of metoprolol succinate, telmisartan, and cilnidipine is recently approved to treat hypertension effectively. A reversed‐phase liquid chromatography method was developed to quantify the said compounds, combining analytical eco‐scale and quality‐by‐design approach. The former one revealed an excellent green score for the present method. Later, method variables were assessed for risks and optimized using the quality‐by‐design‐oriented method development. The optimization process included using a Box‐Behnken design, and the obtained response surfaces for resolution amongst target peaks were mapped systematically. The optimal separation conditions employed a mobile phase of methanol: 0.01 M KH2PO4 buffer of pH 3.0 (70:30, %v/v) flowing at a rate of 1.0 mL/min on a C18 column with diode array detection at 240 nm. All three analyte peaks were well separated from each other with a resolution greater than 2.0. The analytical method was linear (2.5‐80 μg/mL) for target compounds with accuracy (>99%), and precision (<1%) results complying with regulatory requirements. The results of detection and quantitation limits, solution stability, and system suitability limit were good and acceptable. The current method selectively quantified the analytes from commercial dosage forms. Overall a green analytical method is developed and suitable for estimating metoprolol, telmisartan, and cilnidipine simultaneously in their combined pharmaceutical formulations.

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A Quality by Design (QbD) approach to the development of a gradient high-performance liquid chromatography for the simultaneous assay of curcuminoids and doxorubicin from long-circulating liposomes

Cited by 35 publications

References 36 publications

Standardization of Trigonella foenum-graecum L. Seeds: A Quality by Design Approach

Standardization of Trigonella foenum-graecum L. Seeds: A Quality by Design Approach

Key information related to quality by design (QbD) applications in analytical methods development

Analytical eco‐scale and quality by design‐oriented liquid chromatography method for simultaneous quantification of metoprolol succinate, telmisartan, and cilnidipine in their fixed‐dose combination

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