Box–Behnken design aided optimization and validation of developed reverse phase HPLC analytical method for simultaneous quantification of dolutegravir sodium and lamivudine co‐loaded in nano‐liposomes

A stability‐indicating reversed‐phase high‐performance liquid chromatography method for simultaneous estimation of dolutegravir sodium and lamivudine encapsulated in the nanoliposomal formulation was developed. The chromatographic parameters namely, organic phase ratio, flow rate, and sample injecti...

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Vydané v:Journal of separation science Ročník 44; číslo 15; s. 2917 - 2931
Hlavní autori: Mutalik, Sadhana P, Mullick, Prashansha, Pandey, Abhijeet, Kulkarni, Smita S., Mutalik, Srinivas
Médium: Journal Article
Jazyk:English
Vydavateľské údaje: Germany Wiley Subscription Services, Inc 01.08.2021
Predmet:
Acetonitrile
Acidification
Antiretroviral drugs
Box–Behnken design
Chromatography
Chromatography, High Pressure Liquid - methods
Chromatography, Reverse-Phase - methods
Design optimization
dolutegravir
Drug Carriers
Drug Compounding
drugs
experimental design
Flow velocity
Heterocyclic Compounds, 3-Ring - analysis
High-performance liquid chromatography
HIV Integrase Inhibitors - analysis
Ions
lamivudine
Lamivudine - analysis
Limit of Detection
Liposomes
liquid chromatography
Mathematical analysis
methanol
Nanoparticles
nano‐liposomes
Oxazines - analysis
Parameters
Phase ratio
phosphoric acid
Piperazines - analysis
Pyridones - analysis
Reverse Transcriptase Inhibitors - analysis
reversed-phase high performance liquid chromatography
separation
Sodium
liquid chromatography
nano-liposomes
dolutegravir
Box-Behnken design
lamivudine
ISSN:1615-9306, 1615-9314, 1615-9314
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Shrnutí:A stability‐indicating reversed‐phase high‐performance liquid chromatography method for simultaneous estimation of dolutegravir sodium and lamivudine encapsulated in the nanoliposomal formulation was developed. The chromatographic parameters namely, organic phase ratio, flow rate, and sample injection volume were selected as independent factors and were optimized by multivariate Box–Behnken design. Responses analyzed were retention time, peak area, and resolution. The optimized chromatographic method with Hypersil BDS C8 CN column as stationary phase and methanol and acetonitrile mixture and acidified Milli‐Q water (pH 2.8, adjusted with 0.02% v/v orthophosphoric acid) as the mobile phase in an isocratic elution mode was validated according to parameters of International Conference on Harmonization Q1(R2) guidelines. The validated reversed‐phase high‐performance liquid chromatography method exhibited specificity for both dolutegravir sodium and lamivudine in the presence of degradation products as well as the liposomal matrix. This method was effectively utilized to determine the amount of drug entrapped and drug loading efficiency of dolutegravir sodium and lamivudine in a nano‐liposomal formulation.
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ISSN:1615-9306
1615-9314
1615-9314
DOI:10.1002/jssc.202100152