title: Development and Validation of Reversed-Phase High Performance Liquid Chromatographic Method for Hydroxychloroquine Sulphate.
abstract: In the present work new, simple reversed-phase high performance liquid chromatographic method was developed and validated for the determination of hydroxychloroquine sulphate in blood plasma. Chloroquine sulphate was used as an internal standard. The chromatographic separation was achieved with octadecyl silane Hypersil C18 column (250×6 mm, 5 μm) using water and organic (acetonitrile:methanol: 50:50, v/v) mobile phase in 75:25 v/v ratio, with sodium 1-pentanesulfonate and phosphoric acid. This organic phase was maintained at pH 3.0 by orthophosphoric acid. The flow rate of 2.0 ml/min(.) with detection at 343 nm was used in the analysis. The calibration curve of standard hydroxychloroquine sulphate was linear in range 0.1-20.0 μg/ml. The method was validated with respected to linearity, range, precision, accuracy, specificity and robustness studies according to ICH guidelines. The method was found to be accurate and robust to analyze the hydroxychloroquine sulphate in plasma samples.
authors.affiliation: R. V. Northland Institute, Dadri, Gautam Budh Nagar-203 207, India.
authors.forename: A
authors.initials: A
authors.lastname: Singh
authors.affiliation: R. V. Northland Institute, Dadri, Gautam Budh Nagar-203 207, India.
authors.lastname: Roopkishora
authors.affiliation: R. V. Northland Institute, Dadri, Gautam Budh Nagar-203 207, India.
authors.forename: C L
authors.initials: CL
authors.lastname: Singh
authors.affiliation: R. V. Northland Institute, Dadri, Gautam Budh Nagar-203 207, India.
authors.forename: R
authors.initials: R
authors.lastname: Gupta
authors.affiliation: R. V. Northland Institute, Dadri, Gautam Budh Nagar-203 207, India.
authors.forename: S
authors.initials: S
authors.lastname: Kumar
authors.affiliation: KPS, Clinical Services, Greater Noida, Gautam Budh Nagar-201 306, India.
authors.forename: M
authors.initials: M
authors.lastname: Kumar
keywords: Hydroxychloroquine sulphate; ICH guidelines; antimalarial agent; chloroquine sulphate; rheumatoid arthritis