Abstract
Teneligliptin is a new FDA approved drug for treating Diabetes Mellitus. There are no reported evidences for their identified degradation products and their effects on humans. A simple and new stability indicating RP-HPLC method was developed and validated for identification of Teneligliptin and its degradants on Kromasil 100- 5C18 (250×4.6mm, 5μm) column using pH 6.0 phosphate buffer and acetonitrile (60:40 v/v) as a mobile phase in isocratic mode of elution at a flow rate of 1.0 mL/min. The column effluents were monitored by a variable wavelength UV detector at 246 nm. The method was validated as per ICH guidelines. Forced degradation studies of Teneligliptin were carried out under acidic, basic, neutral (peroxide), photo and thermal conditions for 48 hours at room temperature. The degradation products were identified by HPLC and characterized by UPLC with tandem mass spectroscopy (LC/MS/MS). UPLC MS/MS data shown major peaks, observed at 375.72, 354.30, 310.30, 214.19, 155.65, 138.08 and 136.18 m/z. Degradation was observed in base, peroxide and thermal stressed samples, but not in acid and photolytic stressed samples.
Highlights
Teneligliptin is a new FDA approved drug for treating Diabetes Mellitus
The degradation products were identified by HPLC and characterized by ultra-performance liquid chromatography (UPLC) with tandem mass spectroscopy (LC/MS/MS)
R Hydrogen peroxide degradation T Forced degradation of teneligliptin was studied under the influence of (3 %) hydrogen peroxide maintained at RE 35 °C for 48 h
Summary
E studies, UPLC system consisting of gradient mode pump with column Acquity UPLC@ BEH C18 T 100-5-C18 using a mobile phase consisting of a mixture of pH 6.0 phosphate buffer and acetonitrile (60:40 v/v) under. LC/MS conditions Chromatographic separation was achieved on Acquity UPLC@ BEH C18 1.7 μm, 2.1 × 50 mm using the gradient mobile phase consisting of A (10 % acetonitrile in water with 0.1 % formic acid) and B (90 % acetonitrile with 0.1 % formic acid). The eluted components were detected using PDA at a range of 200–400 nm. Sample preparation 1000 μg/mL solution of teneligliptin was prepared by dissolving the required amount of the drug in methanol. The solution was adequately diluted with methanol for accuracy, precision, linearity, limit of detection, and quantification studies. Methanol and filtered through a 0.45-μm membrane before its analysis
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