Development and validation of an HPLC method to quantify camptothecin in polymeric nanocapsule suspensions.
A simple, rapid, and sensitive reversed-phase column high-performance liquid chromatographic method was developed and validated to quantify camptothecin (CPT) in polymeric nanocapsule suspensions. The chromatographic separation was performed on a Supelcosil LC-18 column (15 cm x 4.6 mm id, 5 microm) using a mobile phase consisting of methanol-10 mM KH2PO4 (60 + 40, v/v; pH 2.8) at a flow rate of 1.0 mL/min and ultraviolet detection at 254 nm. The calibration graph was linear from 0.5 to 3.0 microg/mL with a correlation coefficient of 0.9979, and the limit of quantitation was 0.35 microg/mL. The assay recovery ranged from 97.3 to 105.0%. The intraday and interday relative standard deviation values were < 5.0%. The validation results confirmed that the developed method is specific, linear, accurate, and precise for its intended use. The current method was successfully applied to the evaluation of CPT entrapment efficiency and drug content in polymeric nanocapsule suspensions during the early stage of formulation development.
Granada
Andréa
A
Universidade Federal de Santa Catarina, Departamento de Ciências Farmacêuticas, Laboratório de Farmacotécnica, Campus Universitário Trindade, Florianópolis, SC 88040-900, Brazil.
Murakami
Fabio S
FS
Sartori
Tatiane
T
Lemos-Senna
Elenara
E
Silva
Marcos A S
MA
D000972:Antineoplastic Agents, Phytogenic / Q000008:administration & dosage / Q000032:analysis / Q000592:standards; D002166:Camptothecin / Q000008:administration & dosage / Q000032:analysis* / Q000592:standards; D002626:Chemistry, Pharmaceutical; D002851:Chromatography, High Pressure Liquid / Q000379:methods* / Q000592:standards / Q000706:statistics & numerical data; D003692:Delayed-Action Preparations; D006801:Humans; D053769:Nanocapsules; D011108:Polymers; D012015:Reference Standards; D012680:Sensitivity and Specificity; D013535:Suspensions
D000972:Antineoplastic Agents, Phytogenic; D003692:Delayed-Action Preparations; D053769:Nanocapsules; D011108:Polymers; D013535:Suspensions; D002166:Camptothecin