Background: Teneligliptin is a new FDA approved drug for treating Diabetes Mellitus. There are no reported evidences for its degradation products during stability studies and their effects on humans. Methods: A simple and new stability indicating RP-HPLC method was developed and validated for identification of Teneligliptin and its degradants on Kromasil 100-5C 18 (250 × 4.6 mm, 5 μm) 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). Results: 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. Their structural elucidation was depicted. Conclusion: Degradation was observed in base, peroxide and thermal stressed samples, but not in acid and photolytic stressed samples.
A stability indicating RP-HPLC method was developed for the simultaneous estimation of the anti hypertensive drugs Hydrochlorothiazide, Amlodipine Besylate and Telemisartan. These drugs were subjected to stress studies under different conditions as per ICH guidelines. The separations were carried out using C 18 reverse phase column (Agilent ODS UG 5 column, 250mm x 4.5mm,5µm) employing Acetonitrile and Acetate buffer (60:40 v/v) as mobile phase and pH adjusted to 5 at flow rate of 1ml/min was used for separation, detected at 333 nm. The drugs were exposed to acidic, alkaline, oxidative, thermal and photolytic conditions and the stressed samples were analyzed by the proposed method. Degradation studies showed that all the three drugs were degraded under oxidative, thermal and photolytic conditions, negligible degradation observed under acidic, alkaline conditions. Analytical validation parameters such as specificity, linearity, accuracy, precision, Ruggedness and Robustness were determined and relative standard deviation of all the parameters were found to be less than 2%. Hence this method was found to be stable indicator that can be used for the routine analysis of these drugs in the bulk and combined tablet dosage form.
In the present study, novel derivatives of 1,3,4-oxadiazoles were synthesised using optimised chemical reaction methods. The compounds were also screened for their antioxidant and anticancer activity. Four compounds (4, 5b, 5c and 5i) were found active against HepG2 cells and two compounds (5d and 5h) against Hep 2 cells. Thus promising molecules were identified for their anticancer activity.
Background: 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. Methods: 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). Results: 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. Conclusion: Degradation was observed in base, peroxide and thermal stressed samples, but not in acid and photolytic stressed samples.
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