TY - JOUR
T1 - 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
AU - Mutalik, Sadhana P.
AU - Mullick, Prashansha
AU - Pandey, Abhijeet
AU - Kulkarni, Smita S.
AU - Mutalik, Srinivas
N1 - Funding Information:
The authors are thankful for the (i) Department of Science and Technology (DST), Government of India, New Delhi, for providing INSPIRE fellowship to Ms. Sadhana P Mutalik, (ii) Indian Council for Medical Research (ICMR), Government of India, New Delhi, for providing Senior Research Fellowship to Ms Prashansha Mullick, and (iii) Manipal Academy of Higher Education, Manipal, for providing Postdoctoral Research Fellowship to Dr Abhijeet Pandey. The authors are grateful to Orbicular Pharmaceutical Technologies Pvt. Ltd, Hyderabad, India, and Lipoid (Germany) for providing gift samples of drugs and lipids, respectively. The authors are thankful to Manipal College of Pharmaceutical Sciences, Manipal Academy of Higher Education, Manipal for providing the facilities and support.
Publisher Copyright:
© 2021 Wiley-VCH GmbH
PY - 2021/8
Y1 - 2021/8
N2 - 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.
AB - 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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U2 - 10.1002/jssc.202100152
DO - 10.1002/jssc.202100152
M3 - Article
C2 - 34076952
AN - SCOPUS:85108121030
SN - 1615-9306
VL - 44
SP - 2917
EP - 2931
JO - Journal of Separation Science
JF - Journal of Separation Science
IS - 15
ER -