QbD based RP-HPLC method for simultaneous determination of a emtricitabine, tenofovir diproxil fumarate and efavirenz in tablet dosage form-an application to stability indicating assay

Koppisetty, Bhagavan Rajesh Babu; Tatapudi, Hemant Kumar; Dadi, Vasudha; Gayathri, Puthi Renuka; Komali, Pydi; Challa, Gangu Naidu; Kollabathula, Varaprasada Rao; Yarraguntla, Srinivasa Rao

doi:10.1080/22297928.2023.2243279

Analytical Chemistry Letters

2023

DOI: 10.1080/22297928.2023.2243279

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QbD based RP-HPLC method for simultaneous determination of a emtricitabine, tenofovir diproxil fumarate and efavirenz in tablet dosage form-an application to stability indicating assay

Bhagavan Rajesh Babu Koppisetty,

Hemant Kumar Tatapudi,

Vasudha Dadi

et al.

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2024

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Cited by 2 publications

References 22 publications

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Quality by Design‐Assisted RP‐HPLC Method for Determination of Ritonavir and Darunavir in Pharmaceutical Formulation Using Central Composite Design

Koppisetty,

Kollabathula,

Challa

et al. 2024

Separation Science Plus

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The quality by design enabled the development of cost‐effective, simple, precise, and rapid Reversed phase‐ high‐performance liquid chromatography techniques for determining ritonavir (RIT) and darunavir (DAR) in the tablet dosage form. Systematic method optimization was performed through central composite design by altering the flow rate and composition of the organic phase in the mobile phase as the critical method parameters for evaluating the necessary analytical attributes, namely, the tailing factor, theoretical plate count, and resolution. The optimal separation was achieved on a column with C18 in nature and dimensions of (250 mm length × 4.6 mm id × 5 µm particle size) using a mobile phase consisting of acetonitrile and water (75:25 v/v) at a flow rate of 0.9 mL/min. Detection was carried out at 247 nm. The retention time of DAR and RIT was 2.939 and 3.537 min, respectively, as per International Council for Harmonization (ICH) guidelines. The developed method was useful for the determination of bulk drug and formulations.

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Quality by Design‐Assisted RP‐HPLC Method for Determination of Ritonavir and Darunavir in Pharmaceutical Formulation Using Central Composite Design

Koppisetty,

Kollabathula,

Challa

et al. 2024

Separation Science Plus

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Quality by Design Assisted Rp-HPLC Method for Estimation of Teriflunomide and Its Process Impurities in Drug Substance

Dadi,

Medapati,

Baratam

et al. 2024

Ankara Ecz. Fak. Derg.

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Objective: In this research, a validated RP-HPLC method for analyzing teriflunomide drug substance and its associated process-related impurities was developed with the assistance of the Quality by Design (QbD) approach. Material and Method: The QbD methodology employs statistical design of experiments to establish a robust method within a defined "design space." This design space outlines the experimental parameters' range within which alterations will not significantly impact the results. Chromatographic separation was done on HPLC system connected to a PDA detector, and the column used was the C18 YmC-Triart with specifications of 125 cm x 4.0 mm x 5.0 μm. The optimized mobile phase consisted of 0.5% triethylamine buffer with pH 4.0 (± 0.05) and acetonitrile in a 65:35 v/v ratio, flow rate of 1.0 ml/min. Detection wavelength of 210 nm. Result and Discussion: The developed RP-HPLC method successfully achieved high resolution, specificity, linearity, precision, accuracy, and robustness in quantifying both teriflunomide and its impurities simultaneously. Using a design of experiments (DoE) approach, critical method parameters were systematically identified and optimized, ensuring accurate and precise determination of impurity levels across the drug substance lifecycle. This validated method provides a thorough approach to ensuring the quality and safety of teriflunomide drug substances by delivering reliable data on impurity profiles. By applying Quality by Design (QbD) principles, not only does the method enhance understanding of the analytical process, but it also supports ongoing improvement and lifecycle management of the procedure.

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QbD based RP-HPLC method for simultaneous determination of a emtricitabine, tenofovir diproxil fumarate and efavirenz in tablet dosage form-an application to stability indicating assay

Cited by 2 publications

References 22 publications

Quality by Design‐Assisted RP‐HPLC Method for Determination of Ritonavir and Darunavir in Pharmaceutical Formulation Using Central Composite Design

Quality by Design‐Assisted RP‐HPLC Method for Determination of Ritonavir and Darunavir in Pharmaceutical Formulation Using Central Composite Design

Quality by Design Assisted Rp-HPLC Method for Estimation of Teriflunomide and Its Process Impurities in Drug Substance

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