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Determination of rosuvastatin in rat plasma by HPLC: Validation and its application to pharmacokinetic studies.
Biomed Chromatogr. 2006 Sep; 20(9):881-7.BC

Abstract

A specific, accurate, precise and reproducible high-performance liquid chromatography (HPLC) method was developed for the estimation of rosuvastatin (RST), a novel, synthetic and potent HMG-CoA inhibitor in rat plasma. The assay procedure involved simple liquid-liquid extraction of RST and internal standard (IS, ketoprofen) from a small plasma volume directly into acetonitrile. The organic layer was separated and evaporated under a gentle stream of nitrogen at 40 degrees C. The residue was reconstituted in the mobile phase and injected onto a Kromasil KR 100-5C18 column (4.6 x 250 mm, 5 microm). Mobile phase consisting of 0.05 m formic acid and acetonitrile (55:45, v/v) was used at a flow rate of 1.0 mL/min for the effective separation of RST and IS. The detection of the analyte peak was achieved by monitoring the eluate using a UV detector set at 240 nm. The ratio of peak area of analyte to IS was used for quantification of plasma samples. Nominal retention times of RST and IS were 8.6 and 12.5 min, respectively. The standard curve for RST was linear (r2 > 0.999) in the concentration range 0.02-10 microg/mL. Absolute recoveries of RST and IS were 85-110 and >100%, respectively, from rat plasma. The lower limit of quantification (LLOQ) of RST was 0.02 microg/mL. The inter- and intra-day precisions in the measurement of quality control (QC) samples, 0.02, 0.06, 1.6 and 8.0 microg/mL, were in the range 7.24-12.43% relative standard deviation (RSD) and 2.28-10.23% RSD, respectively. Accuracy in the measurement of QC samples was in the range 93.05-112.17% of the spiked nominal values. Both analyte and IS were stable in the battery of stability studies, viz. benchtop, autosampler and freeze-thaw cycles. RST was found to be stable for a period of 30 days on storage at -80 degrees C. The application of the assay to determine the pharmacokinetic disposition after a single oral dose to rats is described.

Authors+Show Affiliations

Drug Metabolism and Pharmacokinetics, Discovery Research, Dr Reddy's Laboratories Ltd, Miyapur, Hyderabad 500 049, India.No affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Journal Article
Validation Study

Language

eng

PubMed ID

16389642

Citation

Kumar, Thammera Ranjith, et al. "Determination of Rosuvastatin in Rat Plasma By HPLC: Validation and Its Application to Pharmacokinetic Studies." Biomedical Chromatography : BMC, vol. 20, no. 9, 2006, pp. 881-7.
Kumar TR, Shitut NR, Kumar PK, et al. Determination of rosuvastatin in rat plasma by HPLC: Validation and its application to pharmacokinetic studies. Biomed Chromatogr. 2006;20(9):881-7.
Kumar, T. R., Shitut, N. R., Kumar, P. K., Vinu, M. C., Kumar, V. V., Mullangi, R., & Srinivas, N. R. (2006). Determination of rosuvastatin in rat plasma by HPLC: Validation and its application to pharmacokinetic studies. Biomedical Chromatography : BMC, 20(9), 881-7.
Kumar TR, et al. Determination of Rosuvastatin in Rat Plasma By HPLC: Validation and Its Application to Pharmacokinetic Studies. Biomed Chromatogr. 2006;20(9):881-7. PubMed PMID: 16389642.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Determination of rosuvastatin in rat plasma by HPLC: Validation and its application to pharmacokinetic studies. AU - Kumar,Thammera Ranjith, AU - Shitut,Nikhil R, AU - Kumar,Pasikanti Kishore, AU - Vinu,Menon C A, AU - Kumar,Venkata V Pavan, AU - Mullangi,Ramesh, AU - Srinivas,Nuggehally R, PY - 2006/1/4/pubmed PY - 2006/12/9/medline PY - 2006/1/4/entrez SP - 881 EP - 7 JF - Biomedical chromatography : BMC JO - Biomed Chromatogr VL - 20 IS - 9 N2 - A specific, accurate, precise and reproducible high-performance liquid chromatography (HPLC) method was developed for the estimation of rosuvastatin (RST), a novel, synthetic and potent HMG-CoA inhibitor in rat plasma. The assay procedure involved simple liquid-liquid extraction of RST and internal standard (IS, ketoprofen) from a small plasma volume directly into acetonitrile. The organic layer was separated and evaporated under a gentle stream of nitrogen at 40 degrees C. The residue was reconstituted in the mobile phase and injected onto a Kromasil KR 100-5C18 column (4.6 x 250 mm, 5 microm). Mobile phase consisting of 0.05 m formic acid and acetonitrile (55:45, v/v) was used at a flow rate of 1.0 mL/min for the effective separation of RST and IS. The detection of the analyte peak was achieved by monitoring the eluate using a UV detector set at 240 nm. The ratio of peak area of analyte to IS was used for quantification of plasma samples. Nominal retention times of RST and IS were 8.6 and 12.5 min, respectively. The standard curve for RST was linear (r2 > 0.999) in the concentration range 0.02-10 microg/mL. Absolute recoveries of RST and IS were 85-110 and >100%, respectively, from rat plasma. The lower limit of quantification (LLOQ) of RST was 0.02 microg/mL. The inter- and intra-day precisions in the measurement of quality control (QC) samples, 0.02, 0.06, 1.6 and 8.0 microg/mL, were in the range 7.24-12.43% relative standard deviation (RSD) and 2.28-10.23% RSD, respectively. Accuracy in the measurement of QC samples was in the range 93.05-112.17% of the spiked nominal values. Both analyte and IS were stable in the battery of stability studies, viz. benchtop, autosampler and freeze-thaw cycles. RST was found to be stable for a period of 30 days on storage at -80 degrees C. The application of the assay to determine the pharmacokinetic disposition after a single oral dose to rats is described. SN - 0269-3879 UR - https://www.unboundmedicine.com/medline/citation/16389642/Determination_of_rosuvastatin_in_rat_plasma_by_HPLC:_Validation_and_its_application_to_pharmacokinetic_studies_ L2 - https://doi.org/10.1002/bmc.611 DB - PRIME DP - Unbound Medicine ER -