QbD-steered development and validation of an RP-HPLC method for quantification of ferulic acid: Rational application of chemometric tools

Saini, Sumant; Sharma, Teenu; Patel, Asha; Kaur, Ranjot; Tripathi, S. K.; Katare, Om Prakash; Singh, Bhupinder

doi:10.1016/j.jchromb.2020.122300

Cited by 36 publications

(24 citation statements)

References 46 publications

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“…Many analytical techniques have been developed and validated for the quantitative determination of CA and FA from various natural sources, including voltammetry [ 25 , 26 ], UV-VIS spectrophotometry [ 27 ], near-infrared spectrophotometry (NIRS) [ 28 ], and chemiluminescence [ 29 ]. However, the literature indicates that the most common technique for this purpose is high-performance liquid chromatography with diode-array or ultraviolet-visible detection (HPLC-DAD or HPLC-UV/ViS) [ 30 , 31 , 32 ]. The determination of natural antioxidants by HPLC is a rapid and simple technique, but also has some limitations, especially in terms of sensitivity and the matrix effect [ 33 ].…”

Section: Introductionmentioning

confidence: 99%

Validated Stability-Indicating GC-MS Method for Characterization of Forced Degradation Products of Trans-Caffeic Acid and Trans-Ferulic Acid

2021

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When dealing with simple phenols such as caffeic acid (CA) and ferulic acid (FA), found in a variety of plants, it is very important to have control over the most important factors that accelerate their degradation reactions. This is the first report in which the stabilities of these two compounds have been systematically tested by exposure to various different factors. Forced degradation studies were performed on pure standards (trans-CA and trans-FA), dissolved in different solvents and exposed to different oxidative, photolytic and thermal stress conditions. Additionally, a rapid, sensitive, and selective stability-indicating gas chromatographic-mass spectrometric method was developed and validated for determination of trans-CA and trans-FA in the presence of their degradation products. Cis-CA and cis-FA were confirmed as the only degradation products in all the experiments performed. All the compounds were perfectly separated by gas chromatography (GC) and identified using mass spectrometry (MS), a method that additionally elucidated their structures. In general, more protic solvents, higher temperatures, UV radiation and longer storage times led to more significant degradation (isomerization) of both trans-isomers. The most progressive isomerization of both compounds (up to 43%) was observed when the polar solutions were exposed to daylight at room temperature for 1 month. The method was validated for linearity, precision as repeatability, limit of detection (LOD) and limit of quantitation (LOQ). The method was confirmed as linear over tested concentration ranges from 1−100 mg L−1 (r2s were above 0.999). The LOD and LOQ for trans-FA were 0.15 mg L−1 and 0.50 mg L−1, respectively. The LOD and LOQ for trans-CA were 0.23 mg L−1 and 0.77 mg L−1, respectively.

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Section: Introductionmentioning

confidence: 99%

Validated Stability-Indicating GC-MS Method for Characterization of Forced Degradation Products of Trans-Caffeic Acid and Trans-Ferulic Acid

2021

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“…It comprises inner and outer arrays which can be used to evaluate the experimental condition that are less likely to be affected by environmental factors (61). Nowadays, Taguchi design is preferentially used as a screening tool in AQbD-based LC studies (62,63). Sequential designs are intended for use in preliminary studies when the analyst isn't familiar with the part of experimental domain that should be examined (7).…”

Section: Other Designsmentioning

confidence: 99%

“…Literature survey revealed tremendous number of HPLC methods that were developed using DoE-based AQbD approach in recent years (23,62,69,(71)(72)(73). In most studies, CCD and D-optimal designs were favorably used to optimize HPLC systems with 2 critical method parameters (CMPs) and BBD in case of 3 or 4 CMPs.…”

Section: Regulatory Aspects Related To Doe In Hplc Analysismentioning

confidence: 99%

Experimental design in HPLC separation of pharmaceuticals

Stojanović¹,

Krmar²,

Protić³

et al. 2021

Arhiv za farmaciju

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Design of Experiments (DoE) is an indispensable tool in contemporary drug analysis as it simultaneously balances a number of chromatographic parameters to ensure optimal separation in High Pressure Liquid Chromatography (HPLC). This manuscript briefly outlines the theoretical background of the DOE and provides step-by-step instruction for its implementation in HPLC pharmaceutical practice. It particularly discusses the classification of various design types and their possibilities to rationalize the different stages of HPLC method development workflow, such as the selection of the most influential factors, factors optimization and assessment of the method robustness. Additionally, the application of the DOE-based Analytical Quality by Design (AQbD) concept in the LC method development has been summarized. Recent achievements in the use of DOE in the development of stability-indicating LC and hyphenated LC-MS methods have also been briefly reported. Performing of Quantitative structure retention relationship (QSRR) study enhanced with DOE-based data collection was recomended as a future perspective in description of retention in HPLC system.

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“…In the case of HPLC methods, the CMPs with high risk assessment are those regarding the material, instrumental parameters, mobile phase (buffer type, concentration, and pH, organic modifier, elution method), column characteristics and preparation, and the analyst. In general, for risk identification and assessment, Ishikawa fishbone diagram can be used (Figure 2) [42][43][44][45][46].…”

Section: Introductionmentioning

confidence: 99%

Implementation of QbD Approach to the Analytical Method Development and Validation for the Estimation of Metformin Hydrochloride in Tablet Dosage Forms by HPLC

et al. 2022

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The current studies entail quality by design (QbD)-enabled development of a simple, rapid, precise, accurate, and cost-effective high-performance liquid chromatographic method for estimation of metformin hydrochloride (M-HCl). Design of experiments (DoE) was applied for multivariate optimization of the experimental conditions of the HPLC method. Risk assessment was performed to identify the critical method parameters (CMPs) using Ishikawa diagram. The factor screening studies were performed using a two-factor three-levels design. Two independent factors, buffer pH and mobile phase composition, were used to design mathematical models. Central composite design (CCD) was used to study the response surface methodology and to study in depth the effects of these independent factors, thus evaluating the critical analytical attributes (CAAs), namely, retention time, peak area, and symmetry factor as the parameters of method robustness. Desirability function was used to simultaneously optimize the CAAs. The optimized and predicted data from contour diagram consisted of 0.02 M acetate buffer pH = 3/methanol in a ratio of 70/30 (v/v) as the mobile phase with a flow rate 1 mL/min. The separation was made on a Thermoscientific ODS HypersylTM chromatographic column (250 × 4.6 mm, 5 μm) with oven temperature 35 °C and UV detection at 235 nm. The optimized assay conditions were validated according to ICH guidelines. Hence, the results clearly showed that QbD approach could be successfully applied to optimize HPLC method for estimation of M-HCl. The method was applied both for the evaluation of M-HCl content in tablets, and for in vitro dissolution studies of M-HCl from conventional and prolonged-release tablets.

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QbD-steered development and validation of an RP-HPLC method for quantification of ferulic acid: Rational application of chemometric tools

Cited by 36 publications

References 46 publications

Validated Stability-Indicating GC-MS Method for Characterization of Forced Degradation Products of Trans-Caffeic Acid and Trans-Ferulic Acid

Validated Stability-Indicating GC-MS Method for Characterization of Forced Degradation Products of Trans-Caffeic Acid and Trans-Ferulic Acid

Experimental design in HPLC separation of pharmaceuticals

Implementation of QbD Approach to the Analytical Method Development and Validation for the Estimation of Metformin Hydrochloride in Tablet Dosage Forms by HPLC

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