Repository of Research and Investigative Information

Repository of Research and Investigative Information

Kurdistan University of Medical Sciences

Determination of tropicamide in pharmaceutical formulations using high-performance liquid chromatography

(2005) Determination of tropicamide in pharmaceutical formulations using high-performance liquid chromatography. Journal of Chromatography A.

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An isocratic, reversed-phase liquid chromatographic method was developed for determination of tropicamide using atropine as an internal standard in a pharmaceutical dosage form. Tropicamide and atropine sulfate were separated using a μBondapak ODS (C18) column by isocratic elution of mobile phase with flow rate of 2.0 ml/min. The mobile phase composition was methanol-50 mM phosphate buffer (pH 4; 30:70, v/v). The eluate was monitored at 257 nm with detector range setting fixed at 0.01 AUFS. Under these conditions, the retention times were 4.81 min for atropine and 11.89 min for tropicamide. The standard calibration curve was linear over a sample concentration range from 2 to 300 μg/ml, with limit of detection of 0.15 μg/ml. The assay linearity was good (typically r2 = 0.9992) and the standard curves were linear in the detection range. The precision of the method (expressed by relative standard deviation) and the accuracy (mean error in percent) were <5 for both intra- and inter-day assays. Recovery at 80-120 of labeled claim ranged from 98.4 to 100.7 for tropicamide. The proposed method was satisfactorily applied to the determination of tropicamide in pharmaceutical preparation and stability indicating studies. © 2005 Elsevier B.V. All rights reserved.

Item Type: Article
Keywords: Assays; Calibration; Liquid chromatography; Methanol; Stability, Calibration curves; Isocratic elution; Mobile phase; Tropicamide, Drug products, atropine; methanol; phosphate buffered saline; tropicamide, accuracy; acidity; assay; calibration; conference paper; drug formulation; flow rate; high performance liquid chromatography; linear system; priority journal; reversed phase liquid chromatography; standard, Chromatography, High Pressure Liquid; Muscarinic Antagonists; Pharmaceutical Preparations; Reproducibility of Results; Sensitivity and Specificity; Spectrophotometry, Ultraviolet; Tropicamide
Page Range: pp. 136-139
Journal or Publication Title: Journal of Chromatography A
Volume: 1088
Number: 1-2
Identification Number: 10.1016/j.chroma.2004.12.099
ISSN: 00219673
Depositing User: مهندس جمال محمودپور

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