Vol. 1, Issue 3 (2013)
Gas Chromatographic Method Development and Validation of Assay Method for the Determination of Ticlopidine Hydrochloride in Tablets Formulation
Author(s): Kapil L. Dubal, Vijay R. Ram, Govind J. Kher, Pragnesh N. Dave, and Hitendra S. Joshi
Abstract: The objective of the current study was to developed simple, precise and accurate Gas Chromatographic [GC] assay method and validated for determination of Ticlopidine hydrochloride in solid pharmaceutical dosage forms. Separation was achieved on a SGE C5 BPX50 30m x 0.25mm i. d. x 0.25µ capillary column, injector temperature was 290°C, Nitrogen gas used as a Carrier gas with Isothermal Column oven temperature 270°C, the injection volume was 3µl and the detection was carried out at 310°C by using Flame ionization detector. The drug was subjected to oxidation, hydrolysis, photolysis and heat to apply stress condition. The method was validated for specificity, linearity, precision, accuracy, robustness and solution stability. The method was linear in the drug concentration range of 1000-4000 μg ml-1 with a correlation coefficient 0.9980. The precision (relative standard deviation- RSD) amongst six-sample preparation was 0.83 % for repeatability and the intermediate precision [RSD] amongst six-sample preparation was 0.42 %. The accuracy (recovery) was between 99.33 and 101.37 %. Degradation products produced as a result of stress studies did not interfere with detection of Ticlopidine hydrochloride and the assay can thus be considered stability indicating.
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Fig. 1: Chromatogram of standard preparation
Fig. 2: Linearity curve for ticlopidine hydrochloride
Fig. 3: Chromatogram of LOD Study of ticlopidine hydrochloride
Pages: 101-106 | 1530 Views 36 Downloads
How to cite this article:
Kapil L. Dubal, Vijay R. Ram, Govind J. Kher, Pragnesh N. Dave,, Hitendra S. Joshi. Gas Chromatographic Method Development and Validation of Assay Method for the Determination of Ticlopidine Hydrochloride in Tablets Formulation. Int J Chem Stud 2013;1(3):101-106.