Application of design space optimization strategy to the development of LC methods for simultaneous analysis of 18 antiretroviral medicines and 4 major excipients used in various pharmaceutical formulations

Habyalimana, Védaste; Mbinze, Jérémie Kindenge; Yemoa, Achille; Waffo, Christelle; Diallo, Tidiane; Tshilombo, Nicodème Kalenda; Ntokamunda, Justin-Léonard Kadima; Lebrun, Philippe; Hubert, Philippe; Marini, R.D.

doi:10.1016/j.jpba.2017.02.040

Cited by 14 publications

(5 citation statements)

References 13 publications

(5 reference statements)

Supporting

Mentioning

Contrasting

Order By: Relevance

“…DoE and QbD approaches have been used to predict retention in RPLC. − Habyalimana et al have used a design space optimization strategy to develop screening methods for 18 antiretroviral medicines and 4 major excipients used for the treatment of HIV/AIDS. They applied a D-Optimal experimental design based on three factors: pH, gradient time, and temperature and interpreted the responses (retention times at the beginning, apex, and end of the peak were modeled by a multivariate multiple linear model).…”

Section: Prediction Of Retention In Rplcmentioning

confidence: 99%

Prediction of Analyte Retention Time in Liquid Chromatography

2020

View full text Add to dashboard Cite

Section: Prediction Of Retention In Rplcmentioning

confidence: 99%

Prediction of Analyte Retention Time in Liquid Chromatography

2020

View full text Add to dashboard Cite

“…Several other studies have reported on the presence of ARVs in various aquatic environments [4,11,13,14,42,53]. A few studies have reported on the presence of ARVs in African countries [36,1,18,43].…”

Section: Introductionmentioning

confidence: 99%

Method optimisation and application based on solid phase extraction of non steroidal anti-inflammatory drugs, antiretroviral drugs, and a lipid regulator from coastal areas of Durban, South Africa

et al. 2022

View full text Add to dashboard Cite

This study presents an optimized method that is applicable in monitoring the occurrence of pharmaceuticals in a wide range of aquatic environments. The optimised Solid Phase Extraction method is based on Bond Elut Plexa cartridges for the identification and quantification of three non-steroidal anti-inflammatory drugs, three antiretroviral drugs and a lipid regulator in the coastal area of Durban city, South Africa covering four seasons. The extracted compounds are qualitatively and quantitatively detected by a high-performance liquid phase chromatographic instrument coupled to a photodiode array detector. The recoveries range from 62 to 110% with a Relative Standard Deviation of 0.56−4.68%, respectively, for the determination of emtricitabine, tenofovir, naproxen, diclofenac, ibuprofen, efavirenz, and gemfibrozil. The analytical method is validated by spiking estuarine water samples with 5 µg L− 1 of a mixture containing the target pharmaceuticals and the matrix detection limit is established to be 0.62–1.78 µg L− 1 for the target compounds. The optimized method is applied to seasonal monitoring of pharmaceuticals at chosen study sites from winter and spring of 2019 and summer and autumn of 2020. The results indicate the concentration of the pharmaceuticals studied varies with the type of aquatic environment and season.

show abstract

“…According to the International Pharmacopeia 9 th Edition (Edition 2019), the content of TEN and EMT in their combined tablets can be quantified by using RP-HPLC equipped with a C18 column under 19 min-gradient elution. Other types of chromatographic separation were also investigated for the analysis of TEN-EMT mixtures and tablets such as HPTLC [4] and isocratic RP-HPLC [5][6][7][8][9][10]. Although the dominance of HPLC as a premier analytical tool is undeniable, it still has some perceived limitations such as being costly, using large quantities of organic solvents, time-consuming and arduous in particular for regulated testing, requiring scientific judgment and substantial experience for development of a new method and interpretation of unusual results or troubleshooting a problem [11].…”

Section: Introductionmentioning

confidence: 99%

Wavelet Signal Processing Tools for Quantifying and Monitoring the in-vitro Dissolution Profiles of Tenofovir Disoproxil Fumarate and Emtricitabine in Tablets

et al. 2022

View full text Add to dashboard Cite

Abstract. Wavelet signal processing tools were applied to the UV spectral dataset for the quantification and understanding the in vitro dissolution behaviors of tenofovir disoproxil fumarate (TEN) and emtricitabine (EMT) in commercial tablets with low-cost and short analysis time. Preliminary signal analysis tests were staged to determine the most suitable wavelet family or families to monitor in vitro dissolution profiles and quantify the drugs of interest. Of these, Daubechies (db6), Symlets 3 (sym3), Biorthogonal 1.5 (bior1.5) and Coiflets 5 (coif5) continuous wavelet tools have been found to be optimal as they provide the desired results. Calibration curves obtained by regression analysis of the continuous wavelet signal (dependent variable) on concentration (independent variable) were found to be linear in the range of 4.0-52.0 µg/mL for both drugs. The validity of CWT signal processing tools was tested by analyzing mixtures made in the laboratory. The Quantitation of TEN and EMT by the proposed signal processing tools did not require a pre-separation procedure. They were successfully utilized for the assay and in vitro dissolution monitoring of the two drugs in their combined tablets. Consequently, the presented work provided alternative tools based on wavelet signal processing to traditional derivative spectrophotometry to resolve a two-component mixture without using a priori separation step. Resumen. Las herramientas de transformada continua de wavelets fueron empleadas para el procesamiento de espectros de absorción UV con el fin de lograr la cuantificación y la comprensión del comportamiento de fumarato de disoproxilo de tenofovir (TEN) y de emtricitabina (EMT) en la disolución in vitro de las tabletas comerciales, con bajo costo y corto tiempo de análisis. Se realizaron pruebas preliminares de análisis de señales para determinar la familia o familias de ondículas más adecuadas para monitorear los perfiles de disolución in vitro y para cuantificar los fármacos de interés. Entre ellos, las herramientas Daubechies (db6), Symlets 3 (sym3), Biorthogonal 1.5 (bior1.5) y Coiflets 5 (coif5) resultaron ser óptimas proporcionando resultados deseados. Funciones de calibración obtenidas mediante el análisis de regresión de señales de ondículas transformadas (variable dependiente) obtenidas para soluciones de calibración (concentración - variable independiente) presentaron buena linealidad en el intervalo de concentraciones 4.0-52.0 µg/mL para ambos fármacos. La validez de procesamiento de señales CWT fue demostrada mediante el análisis de mezclas de conocidas concentraciones, preparadas en el laboratorio. La cuantificación de TEN y EMT no requiere su separación previa. El procedimiento fue empleado en el ensayo de monitoreo de la disolución in vitro de los fármacos y en las tabletas con contenían los dos fármacos. En este trabajo se propone un procedimiento basado en CWT, alternativo respecto a la tradicional espectrofotometría de derivadas para resolución de mezclas binarias sin necesidad de separación previa de dos componentes.

show abstract

Application of design space optimization strategy to the development of LC methods for simultaneous analysis of 18 antiretroviral medicines and 4 major excipients used in various pharmaceutical formulations

Cited by 14 publications

References 13 publications

Prediction of Analyte Retention Time in Liquid Chromatography

Prediction of Analyte Retention Time in Liquid Chromatography

Method optimisation and application based on solid phase extraction of non steroidal anti-inflammatory drugs, antiretroviral drugs, and a lipid regulator from coastal areas of Durban, South Africa

Wavelet Signal Processing Tools for Quantifying and Monitoring the in-vitro Dissolution Profiles of Tenofovir Disoproxil Fumarate and Emtricitabine in Tablets

Contact Info

Product

Resources

About