Determination of Linagliptin using HPLC Method.

Venkata Naresh Kumar, P (2014) Determination of Linagliptin using HPLC Method. Masters thesis, Edayathangudy G.S. Pillay College of Pharmacy, Nagapattinam.

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Analytical chemistry is a branch of chemistry, which covers a series of subjects covering the science of chemical separation, identification, detection and measurement of a sample. It is mainly involved in the qualitative identification or detection of compounds and quantitative measurement of the substances present in the bulk and pharmaceutical preparation. Qualitative identification provides information about the identity of an atomic, molecular or bimolecular species. Quantitative measurement provides numerical information as to the relative amounts of species. The present study describes sensitive and reproducible method for the quantitative determinationlinagliptin and its degradation behavior. The method was based on high performanceliquid chromatographic separation of the drug on the MicrosorbC8 (25 cms long 4.6mm inner diameter)column at ambient temperature using mobile phase potassiumdihydrogen phosphate(40mM: pH 3) and acetonitrile (70:30, v/v). Flow rate was 1.0mL/min and retention time was found to be 4.19min. Quantitation was achieved with UV detection at 225nm based on peak area with linear calibration curve at concentration range 0.2 - 16μg/mL. This method has been successively applied to pharmaceutical formulation. No chromatographic interference from the tablet excepients was found. The method was validated. Relative standard deviation values for all key parameters were less than 2.0%. Excellent recoveries (98.51 and 99.82%) proved that the method was sufficiently accurate. The LOD and LOQ were found to be 0.06 and 0.18μg/mL, respectively. The RSD valves for intraday and inter-day precision below 2.0%. Acceptable robustness indicates that the assay method remains unaffected by small but deliberate variations.

Item Type: Thesis (Masters)
Uncontrolled Keywords: Linagliptin ; Hplc Method.
Subjects: PHARMACY > Pharmaceutical Analysis
Depositing User: Ravindran C
Date Deposited: 27 Jul 2017 09:40
Last Modified: 12 Oct 2017 02:45

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