Box–Behnken Design-Based Development and Validation of a Reverse-Phase HPLC Analytical Method for the Estimation of Paclitaxel in Cationic Liposomes
نویسندگان
چکیده
Abstract Stability-indicating reverse-phase HPLC analytical method for the quantification of Paclitaxel (PTX) in bulk and cationic liposomes was developed. The optimized validated according to ICH Q2 (R1) guidelines by following a 2-level–4-factor interaction Box–Behnken design using Design-Expert ® software. responses measured at 228 nm were retention time (Rt), peak area, tailing factor (Tf 10% ), number theoretical plates (NTP). PTX eluted best Luna C 18 LC Column along with mobile phase methanol 25 mM ammonium acetate buffer (pH 6) 75:25 v/v mixture ± 2 °C temperature. currently developed linear 2.5–100 µg/mL range detection limit 0.062 0.188 µg/mL. utilized evaluate stability different stress conditions performing forced degradation studies. results from study stipulated that on exposure various stressors, namely acid, alkali, oxidative, thermal, UV light, did not show considerable except alkali exposure. Further, successfully used liposomes. particle size, zeta potential, polydispersity index PTX-loaded 219.25 7.566 nm, 57.15 12.374 mV, 0.807 0.1958 respectively. percent drug entrapped quantified found be 59 1.414%.
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ژورنال
عنوان ژورنال: Chromatographia
سال: 2022
ISSN: ['0009-5893', '1612-1112']
DOI: https://doi.org/10.1007/s10337-022-04172-w