Simple and reliable HPLC method of abacavir determination in pharmaceuticals, human serum and drug dissolution studies from tablets

摘要

This work describes a new, fully validated, simple, rapid, selective, and sensitive HPLC method with UV detection for the direct determination of abacavir in pharmaceutical dosage forms, raw materials, spiked human serum, and drug dissolution studies without any time-consuming extraction or evaporation steps prior to drug assay. The mobile phase employed was methanol: acetonitrile: 0.015 M KH2PO4 (36:2.6:61.4 v/v/v) adjusted to pH 6.9 with 5N NaOH. The samples of 20 muL were injected onto a Waters Spherisorb ODSI (250 x 4.6 mm, 5 mum particle size) column. Ketoprofen was used as internal standard. The flow rate was 1.0 mL min(-1). The retention times were 5.49min for abacavir and 9.15min for ketoprofen in mobile phase, 5.46min for abacavir and 9.24min for ketoprofen in serum samples. The samples were detected at 284mn. The assay was linear in the concentration range 0.010-20 mugmL(-1) (r = 0.999) with a slope of 1.35 x 10(-3); intercept of 0.0841 and the limit of detection was 0.00093 mug mL(-1) in mobile phase and 0.025-20 mug mL(-1) (r = 0.999) with a slope of 1.44 x 10(-3); intercept of 0.0733 and the limit of detection was 0.00418 mug mL(-1) in human serum. The linearity of the detector response for abacavir was determined by plotting peak area ratios vs. concentration. It was successfully applied to the analysis of abacavir pharmaceutical preparations, and human serum samples without any interference by the excipients and endogenous substances. Moreover, the method can be used for the determination of abacavir for monitoring its concentration for in vitro dissolution studies.