Wiadomosci lekarskie (Warsaw, Poland : 1960) · 2026
Optimization and validation of an HPLC method for the quantification of Etodolac in liposomes and assessment of its pharmacokinetic profile.
СтатьяВалидационное исследованиеНазвание и аннотация: Перевод в очереди
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Wais Fatimah M H, Al-Edresi Sarmad
Аннотация
OBJECTIVE: Aim: To develop and evaluate high performance liquid chromatogram method to simultaneously quantify Etodolac in liposomes.
PATIENTS AND METHODS: Materials and Methods: The chromatographic separation was carried out on the C18 column, mobile phase of methanol: acetonitrile: water at a ratio of (30:60:10) and a flow rate of (1ml.min-1), with a detection wavelength of 225 nm. Liposomes were prepared by thin film hydrating method using Distearoylphosphatidylcholine and cholesterol.
RESULTS: Results: Linear concentration range of the assay was 2.5-25 µg.ml-1 with a regression coefficient factor R2 ≥ 0.999 with a retention time of Etodolac 4.11 ± 0.081 min. The method was rigorously validated for linearity, accuracy, precision, specificity, and stability, ensuring its reliability. The concentrations of Etodolac 2.5, 5, 7.5, and 10 µg.ml-1 were used, with the intraday n=6 and intraday n=6 precision and accuracy for Etodolac meeting the accepted criteria of the United States Food and Drug Administration guideline. The limited detection and limited quantification values for Etodolac were 0.42 µg.ml-1 and 1.3 µg.ml-1, respectively. Conventional liposomes have characterization (PZ 88 ± 0.02, PDI 0.012 ± 0.01, %EE 89.5 ± 0.004, and Z-potential -10.2mV ± 0.001), while PEGylated liposomes (PZ 92 ± 0.003, PDI 0.01 ± 0.02, %EE 94.3% ± 0.01, and Z-potential -13.6mV ± 0.012).
CONCLUSION: Conclusions: The developed and validated method of HPLC was successfully applied to determine Etodolac in bulk and liposomes for routine quantitative analysis.
PATIENTS AND METHODS: Materials and Methods: The chromatographic separation was carried out on the C18 column, mobile phase of methanol: acetonitrile: water at a ratio of (30:60:10) and a flow rate of (1ml.min-1), with a detection wavelength of 225 nm. Liposomes were prepared by thin film hydrating method using Distearoylphosphatidylcholine and cholesterol.
RESULTS: Results: Linear concentration range of the assay was 2.5-25 µg.ml-1 with a regression coefficient factor R2 ≥ 0.999 with a retention time of Etodolac 4.11 ± 0.081 min. The method was rigorously validated for linearity, accuracy, precision, specificity, and stability, ensuring its reliability. The concentrations of Etodolac 2.5, 5, 7.5, and 10 µg.ml-1 were used, with the intraday n=6 and intraday n=6 precision and accuracy for Etodolac meeting the accepted criteria of the United States Food and Drug Administration guideline. The limited detection and limited quantification values for Etodolac were 0.42 µg.ml-1 and 1.3 µg.ml-1, respectively. Conventional liposomes have characterization (PZ 88 ± 0.02, PDI 0.012 ± 0.01, %EE 89.5 ± 0.004, and Z-potential -10.2mV ± 0.001), while PEGylated liposomes (PZ 92 ± 0.003, PDI 0.01 ± 0.02, %EE 94.3% ± 0.01, and Z-potential -13.6mV ± 0.012).
CONCLUSION: Conclusions: The developed and validated method of HPLC was successfully applied to determine Etodolac in bulk and liposomes for routine quantitative analysis.