Showing papers in "Journal of analytical and bioanalytical techniques in 2019"
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TL;DR: In this paper, a reverse phase liquid chromatographic method for force degradation behavior of Vildagliptin and its degradation pattern in pharmaceutical dosage forms was presented, which was validated in accordance with International Conference on Harmonization Q2 (R1).
Abstract: Vildagliptin is an anti-diabetic drug under new class of dipeptidyl peptidase-4(DPP-4) inhibitor. The proposed work is performed to develop simple reverse phase liquid chromatographic method for force degradation behavior of Vildagliptin and its degradation pattern in pharmaceutical dosage forms. The chromatographic separation was obtained on C18 column with mobile phase containing acetonitrile and water (40:60) pH adjusted at 7.0 using triethylamine, with a flow rate of 1 ml/min, UV detection at 220 nm. Retention time was found to be 5.3 min and method was linear in the range of 2-12 ug/ml of R2=0.9999. Limit of detection and limit of quantization were 3.61 and 10.96 ug/ml, respectively.
The method was validated in accordance with International Conference on Harmonization Q2 (R1). Stress studies were carried out using acidic, basic, oxidative, thermal and photolytic conditions and there is no interference of the degradation products was observed with main drug peak
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TL;DR: A fast, perceptive, and highly discriminating Liquid chromatographic method with Mass spectroscopy was urbanized and validated for simultaneous determination of Enalapril and its major bioactive metabolite Enalamprilat in human plasma as mentioned in this paper.
Abstract: A fast, perceptive, and highly discriminating Liquid chromatographic method with Mass spectroscopy was urbanized and validated for simultaneous determination of Enalapril and its major bioactive metabolite Enalaprilat in human plasma. Solid phase extraction process was used for the extraction of analytes from plasma. The chromatographic severance was achieved on Zorbax Eclipse; 150 × 4.6 mm, C18 5 µm column using a solvent system of acetonitrile and 0.1% v/v HCOOH in water with a ratio of 65:35 v/v at a flow rate of 0.8 mL/min. The analytes were detected in a positive ionization by multiple reactions monitoring mode. Mass transitions of m/z 377.10 → 234 for Enalapril, m/z 382.10 → 239.20 for Enalapril D5 and m/z 349 → 206 for Enalaprilat, m/z 354.20 → 211.20 for Enalaprilat D5 were used for quantification in plasma samples. The method exhibited a linear response with a Correlation co-efficient (r2) of >0.99 in the concentration range of 0.502-160.2 ng/mL for Enalapril and 0.506-161.5 ng/mL for Enalaprilat in human plasma. The mean recovery of Enalapril was 91.21% with a precision range of 1.72% to 5.06% and Enalaprilat was 90.85% with a precision range of 1.29% to 3.87%. The proposed method can be utilized for the quantification of Enalapril and Enalaprilat in human plasma in regular bioequivalence studies.