Optimization and modeling of a green dual detected RP-HPLC method by UV and fluorescence detectors using two level full factorial design for simultaneous determination of sofosbuvir and ledipasvir: Application to average content and uniformity of dosage unit testing

EL-Shorbagy, Hanan I.; Elsebaei, Fawzi; Hammad, Sherin F.; El-Brashy, A.

doi:10.1016/j.microc.2019.03.039

Cited by 36 publications

(25 citation statements)

References 35 publications

Supporting

Mentioning

Contrasting

Order By: Relevance

“…AES [26,27] represented a score of 100. Penalty point (PP) was calculated and subtracted from the method using five different steps; it was calculated as follows.…”

Section: Eco-friendly Methods Assessmentmentioning

confidence: 99%

Estimation of pitavastatin and ezetimibe using UPLC by a combined approach of analytical quality by design with green analytical technique

Chanduluru

Sugumaran

2022

AChrom

View full text Add to dashboard Cite

The current study explores a design and development of the simple, fast, green and selective novel method of UPLC to quantify pitavastatin and ezetimibe simultaneously. The combined approach of Green Analytical Method with Quality by Design-based risk assessment was done using the Ishikawa fishbone diagram followed by a rotatable central composite design used for the optimization. The optimal chromatographic separation was attained through a mobile phase of 72: 28% v/v ethanol and 0.1% orthophosphoric acid (pH 3.5), with a 0.31 mL min−1 flow rate. The developed UPLC-PDA method was sensitive and specific for pitavastatin and ezetimibe, with linearity ranging from 2 to 30, 10–150 μg mL−1 with an R2 of 0.9999 and 0.9997, respectively. The forced degradation study of stability-indicating assay results shows the degradation in respective stress conditions. The developed UPLC method was validated and found to have sensible results with good linearity, accuracy and precision. Further, the greenness was evaluated using five states of art metrics like NEMI, GAPI, AES, AMGS, and AGREE metrics and found the greenest results. Based on the results we concluded that the developed UPLC method could be efficient for the simultaneous determination of pitavastatin and ezetimibe in bulk and tablet dosage.

show abstract

“…AES [26,27] represented a score of 100. Penalty point (PP) was calculated and subtracted from the method using five different steps; it was calculated as follows.…”

Section: Eco-friendly Methods Assessmentmentioning

confidence: 99%

Estimation of pitavastatin and ezetimibe using UPLC by a combined approach of analytical quality by design with green analytical technique

Chanduluru

Sugumaran

2022

AChrom

View full text Add to dashboard Cite

show abstract

“…The optimum chromatographic separation could be achieved in most of the reported methods via ACN due to its low viscosity and low ultraviolet (UV) cut‐off wavelength (Atia et al, 2018). The addition of hexane sulfonate (Hassouna & Mohamed, 2018) and triethylamine (EL‐Shorbagy et al, 2019; Fares et al, 2019; Mastanamma et al, 2018; Sathiya & Badeliya, 2018; Zidan et al, 2018) was employed to improve the separation process and overcome the peak tailing problems. Acidic buffers were used to increase the ionization of sofosbuvir, a basic analyte, which in turn decreased the affinity of sofosbuvir for the stationary phase and reduced the retention time (EL‐Shorbagy et al, 2019).…”

Section: Hplc Methods For the Analysis Of Sofosbuvirmentioning

confidence: 99%

Recent advances in the chromatographic determination of the most commonly used anti‐hepatitis C drug sofosbuvir and its co‐administered drugs in human plasma

Abdel-Tawab

El-Moghny

Nashar

2021

Biomedical Chromatography

View full text Add to dashboard Cite

Sofosbuvir is a direct‐acting antiviral drug that inhibits hepatitis C virus (HCV) NS5B polymerase, which in turn affects the virus replication inside biological systems. The clinical importance of sofosbuvir is based not only on its effect on HCV but also on other lethal viruses such as Zika and severe acute respiratory syndrome coronavirus disease 2019 (SARS‐COVID‐19). Accordingly, there is a continuous shedding of light on the development and validation of accurate and fast analytical methods for the determination of sofosbuvir in different environments. This work critically reviews the recent advances in chromatographic methods for the analysis of sofosbuvir and/or its metabolites in pure samples, pharmaceutical dosage forms, and in the presence of other co‐administered drugs to highlight the current status and future perspectives to enhance its determination in different matrixes.

show abstract

“…EL‐Shorbagy et al. [18] used a two‐level FFD to optimize a high‐performance liquid chromatography (HPLC) method for the determination of sofosbuvir and ledipasvir. In this study, only three factors were screened as key factors, and each factor was set at only two levels.…”

Section: Fundamentals Of Doementioning

confidence: 99%

“…But the main limitation is that the total test numbers of FFD will increase dramatically with the growing of factors, so it is suitable for the cases that include few factors [17]. EL-Shorbagy et al [18] used a two-level FFD to optimize a high-performance liquid chromatography (HPLC) method for the determination of sofosbuvir and ledipasvir. In this study, only three factors were screened as key factors, and each factor was set at only two levels.…”

Section: Factorial Designs (Fd)mentioning

confidence: 99%

Design of experiment techniques for the optimization of chromatographic analysis conditions: A review

et al. 2022

View full text Add to dashboard Cite

Design of experiment (DoE) techniques have been widely used in the field of chromatographic parameters optimization as a valuable tool. A systematic literature review of the available DoE techniques applied to the development of a chromatographic analysis method is presented in this paper. First, the most common available designs and the implementation steps of DoE are comprehensively introduced. Then the studies in recent 10 years for the application of DoE techniques in various chromatographic techniques are discussed, such as capillary electrophoresis, liquid chromatography, gas chromatography, thin‐layer chromatography, and high‐speed countercurrent chromatography. Current problems and future outlooks are finally given to provide a certain inspiration of research in the application of DoE techniques to the different chromatographic techniques field. This review contributes to a better understanding of the DoE techniques for the efficient optimization of chromatographic analysis conditions, especially for the analysis of complex systems, such as multicomponent drugs and natural products.

show abstract

Optimization and modeling of a green dual detected RP-HPLC method by UV and fluorescence detectors using two level full factorial design for simultaneous determination of sofosbuvir and ledipasvir: Application to average content and uniformity of dosage unit testing

Cited by 36 publications

References 35 publications

Estimation of pitavastatin and ezetimibe using UPLC by a combined approach of analytical quality by design with green analytical technique

Estimation of pitavastatin and ezetimibe using UPLC by a combined approach of analytical quality by design with green analytical technique

Recent advances in the chromatographic determination of the most commonly used anti‐hepatitis C drug sofosbuvir and its co‐administered drugs in human plasma

Design of experiment techniques for the optimization of chromatographic analysis conditions: A review

Contact Info

Product

Resources

About