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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
Author(s) -
Mutalik Sadhana P,
Mullick Prashansha,
Pandey Abhijeet,
Kulkarni Smita S.,
Mutalik Srinivas
Publication year - 2021
Publication title -
journal of separation science
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.72
H-Index - 102
eISSN - 1615-9314
pISSN - 1615-9306
DOI - 10.1002/jssc.202100152
Subject(s) - box–behnken design , dolutegravir , chromatography , lamivudine , chemistry , high performance liquid chromatography , liposome , reversed phase chromatography , materials science , nanotechnology , response surface methodology , virology , virus , viral load , medicine , hepatitis b virus , antiretroviral therapy
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.