Development and Validation of QbD-Driven Bioanalytical LC-MS/MS Method for the Quantification of Paracetamol and Diclofenac in Human Plasma

Bhatt, Preeti; Hasnain, Md Saquib; Nayak, Amit Kumar; Hassan, Bushra; Beg, Sarwar

doi:10.1080/22297928.2018.1429305

Cited by 14 publications

(4 citation statements)

References 39 publications

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“…can be used for robustness testing, small changes in CMPs (flow rate, organic modifier percentage, column temperature, wavelength, etc.) are tested, to evaluate if they have significant effects on CMAs (40,61).…”

Section: Table I Most Frequently Used Methods In Experimental Designsmentioning

confidence: 99%

“…In order to better visualize the effects of the input variables (such as pH, temperature, flow rate, etc.) on CMAs, response surface analysis (2D or 3D response surface plot) can be applied, which shows the complex, non-linear interactions between the studied factors on quality performances (42,61). A general workflow presenting the steps of AQbD is illustrated in Scheme 2 (28,62,63).…”

Section: Table I Most Frequently Used Methods In Experimental Designsmentioning

confidence: 99%

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Quality-by-design in pharmaceutical development: From current perspectives to practical applications

et al. 2021

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Current pharmaceutical research directions tend to follow a systematic approach in the field of applied research and development. The concept of quality-by-design (QbD) has been the focus of the current progress of pharmaceutical sciences. It is based on, but not limited, to risk assessment, design of experiments and other computational methods and process analytical technology. These tools offer a well-organized methodology, both to identify and analyse the hazards that should be handled as critical, and are therefore applicable in the control strategy. Once implemented, the QbD approach will augment the comprehension of experts concerning the developed analytical technique or manufacturing process. The main activities are oriented towards the identification of the quality target product profiles, along with the critical quality attributes, the risk management of these and their analysis through in silico aided methods. This review aims to offer an overview of the current standpoints and general applications of QbD methods in pharmaceutical development.

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Section: Table I Most Frequently Used Methods In Experimental Designsmentioning

confidence: 99%

Section: Table I Most Frequently Used Methods In Experimental Designsmentioning

confidence: 99%

Quality-by-design in pharmaceutical development: From current perspectives to practical applications

et al. 2021

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“…BBD has an advantage over other designs that it requires less number of experiments, thus considerably saving time and effort [18, 19]. A score of research reports is the testimony of having demonstrated the utility of experimental designs in analytical method development [20–31]. For the present study survey of literature revealed that not a single bioanalytical method for ARIP assessed the robustness using the DoE approach which in turn may influence method performance over time.…”

Section: Introductionmentioning

confidence: 96%

A systematized and chemometrics‐assisted liquid chromatography coupled with tandem mass spectrometry method for quantification of aripiprazole in implantable microparticles in rat plasma from pharmacokinetic study

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et al. 2022

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“…Additionally, these techniques offer minimal data on how the different parameters listed above interact with, and ultimately influence, each other. In the past, research has been conducted on the development and application of retaliation surface methodologies for the quantification of various compounds [23][24][25][26][27][28][29][30][31][32][33][34]. Therefore, this research was focused on the development of a Box-Behnken-optimized RP-HPLC method for the quantification of domperidone and lansoprazole in new and unusual solvent systems.…”

Section: Introductionmentioning

confidence: 99%

Box-Behnken Assisted Validation and Optimization of an RP-HPLC Method for Simultaneous Determination of Domperidone and Lansoprazole

et al. 2021

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A highly specific, accurate, and simple RP-HPLC technique was developed for the real-time quantification of domperidone (DOMP) and lansoprazole (LANS) in commercial formulations. Chromatographic studies were performed using a Luna C8(2), 5 μm, 100Å, column (250 × 4.6 mm, Phenomenex) with a mobile phase composed of acetonitrile/2 mM ammonium acetate (51:49 v/v), pH 6.7. The flow rate was 1 mL·min−1 with UV detection at 289 nm. Linearity was observed within the range of 4–36 µg·mL−1 for domperidone and 2–18 µg·mL−1 for lansoprazole. Method optimization was achieved using Box-Behnken design software, in which three key variables were examined, namely, the flow rate (A), the composition of the mobile phase (B), and the pH (C). The retention time (Y1 and Y3) and the peak area (Y2 and Y4) were taken as the response parameters. We observed that slight alterations in the mobile phase and the flow rate influenced the outcome, whereas the pH exerted no effect. Method validation featured various ICH parameters including linearity, limit of detection (LOD), accuracy, precision, ruggedness, robustness, stability, and system suitability. This method is potentially useful for the analysis of commercial formulations and laboratory preparations.

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Development and Validation of QbD-Driven Bioanalytical LC-MS/MS Method for the Quantification of Paracetamol and Diclofenac in Human Plasma

Cited by 14 publications

References 39 publications

Quality-by-design in pharmaceutical development: From current perspectives to practical applications

Quality-by-design in pharmaceutical development: From current perspectives to practical applications

A systematized and chemometrics‐assisted liquid chromatography coupled with tandem mass spectrometry method for quantification of aripiprazole in implantable microparticles in rat plasma from pharmacokinetic study

Box-Behnken Assisted Validation and Optimization of an RP-HPLC Method for Simultaneous Determination of Domperidone and Lansoprazole

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