Quality by design approach for development and validation of a RP-HPLC method for simultaneous determination of co-administered levetiracetam and pyridoxine HCl in prepared tablets

Hashem, Hisham; El‐Sayed, Heba M.

doi:10.1016/j.microc.2018.07.031

Cited by 38 publications

(12 citation statements)

References 19 publications

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“…MeOH (Fischer Scienti c, Hampton, USA), Potassium dihydrogen phosphate (Techno Pharmchem, Delhi, India) and orthophosphoric acid (Merck, India) were all analytical grade assigned [33].…”

Section: Materials and Reagentsmentioning

confidence: 99%

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Quality by Design Approach for Development and Validation of a RP-HPLC Method for Simultaneous Determination of Xipamide and Valsartan in Human Plasma

Sebaiy

El-Adl

Baraka

et al. 2022

Preprint

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A new rapid, simple and sensitive RP-HPLC method was developed through employing Quality by Design (QbD) approach for determination xipamide and valsartan in Human plasma. Fractional factorial design (FFD) was applied for screening of the four independent factors: pH, flow rate, detection wavelength, and % of MeOH. Analysis of variance (ANOVA) confirmed that flow rate and % of MeOH were only significant. The optimization of the chromatographic conditions was carried out through using central composite design (CCD). Method Analysis was achieved using BDS Hypersil C8 (250 × 4.6 mm, 5 µm) column and an isocratic mobile phase of MeOH and 0.05M KH2PO4 buffer pH 3 (64.5:35.5, v/v) at 1.2 mL/min flow rate with UV detection at 240nm and 10 µL injection volume. According to FDA guidelines, the method was then validated for the determination of the two drugs clinically in human plasma in respect of future pharmacokinetic and bioequivalence simulation studies. The standard curve was linear in the concentration range of 5-100 µg/mL for both drugs, with a correlation coefficients (R2) of 0.999. The average recoveries ranged from 99.89 to 100.03%. The proposed method showed good predictability and robustness.

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“…MeOH (Fischer Scienti c, Hampton, USA), Potassium dihydrogen phosphate (Techno Pharmchem, Delhi, India) and orthophosphoric acid (Merck, India) were all analytical grade assigned [33].…”

Section: Materials and Reagentsmentioning

confidence: 99%

“…In addition, acetonitrile and MeOH were tested as organic modi ers. Finally, the variables that may clearly affect the selected responses were chosen [33].…”

Section: Human Plasma Samples Procedurementioning

confidence: 99%

Quality by Design Approach for Development and Validation of a RP-HPLC Method for Simultaneous Determination of Xipamide and Valsartan in Human Plasma

Sebaiy

El-Adl

Baraka

et al. 2022

Preprint

View full text Add to dashboard Cite

show abstract

“…Hashem and El-Sayed [42] proposed a new RP-HPLC method for the simultaneous determination of levetiracetam and pyridoxine HCl in prepared tablets using QbD. Screening of four independent variables: pH of the mobile phase, flow rate, injection volume and percentage of the organic modifier at two levels, and optimization of the chromatographic variables were performed by FFD and CCD, respectively.…”

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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“…Compared to a traditional optimization of analytical method, such as the One-Factor-At-a-time approach, the AQbD approach has several obvious advantages. Firstly, it requires a small number of experiments with the understanding of critical parameters [23]. In addition, AQbD leads to the establishment of the design space, defined as the multidimensional combination and interaction of input variables that have been demonstrated to provide assurance of quality [22].…”

Section: Introductionmentioning

confidence: 99%

Development and optimization of HPLC-MS method for simultaneous determination of four terpene trilactones in Ginkgo biloba leaf extracts based on Quality by Design principles

Zhang

Wang

et al. 2020

Preprint

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Background Ginkgo biloba leaf extract (EGBL) is one of the most commonly used and most studied herbal medicines around the world. Taking into account that previously reported HPLC-ELSD methods for terpene trilactones determination in EGBL are time-consuming with complicated sample preparation, it is reasonable and meaningful to developing a simple, sensitive and robust HPLC-MS method based on a novel analytical quality by design (AQbD) approach. Methods Firstly, analytical target profile (ATP) and systematic risk analysis were carried out to identify potential critical method attributes (CMAs) and critical method parameters (CMPs). Secondly, CMPs were identified using a standard partial regression coefficient method. Thirdly, Box-Behnken design (BBD) was employed to establish the quantitative relationship between CMAs and CMPs. Fourthly, the Monte Carlo simulation method was used to build hypercube design space. Then, the verification experiments were performed. Fifthly, the optimized method was validated and utilized. Finally, the paired t test was used to compare the developed method with HPLC-ELSD. Results After the screening experiments, flow rate of mobile phase, the proportion of formic acid in the mobile phase, gas flow rate and gas temperature were identified as CMPs. Models to quantitatively describe the relationship between CMAs and CMPs were built. The operational hypercube design spaces of the HPLC-MS method for terpene trilactones analysis in EGBL were successfully calculated and found to be robust, which led to the analytical control strategy. The verification experiments were successfully performed within the design space and model was found to be accurate. The method had been successfully used for quality analysis of development batches of EGBL and obtained almost identical results to data determinated using HPLC. Conclusions In this work, an analytical control strategy for HPLC-MS method for terpene trilactones analysis in EGBL was developed using AQbD concepts, which is promising for application to other Chinese medicines. The developed HPLC-MS method is an alternative method for quantification of terpene trilactones in commercial EGBL and will be applicable throughout the life cycle of the product.

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Quality by design approach for development and validation of a RP-HPLC method for simultaneous determination of co-administered levetiracetam and pyridoxine HCl in prepared tablets

Cited by 38 publications

References 19 publications

Quality by Design Approach for Development and Validation of a RP-HPLC Method for Simultaneous Determination of Xipamide and Valsartan in Human Plasma

Quality by Design Approach for Development and Validation of a RP-HPLC Method for Simultaneous Determination of Xipamide and Valsartan in Human Plasma

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

Development and optimization of HPLC-MS method for simultaneous determination of four terpene trilactones in Ginkgo biloba leaf extracts based on Quality by Design principles

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