Simultaneous HPLC determination of vildagliptin, ampicillin, sulbactam and metronidazole in pharmaceutical dosage forms
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ORIGINAL PAPER
Simultaneous HPLC determination of vildagliptin, ampicillin, sulbactam and metronidazole in pharmaceutical dosage forms and human urine Khaled K. Abdel Hady1 · Randa A. Abdel Salam2 · Ghada M. Hadad2 · Eman A. Abdel Hameed3 Received: 7 May 2020 / Accepted: 10 September 2020 © Iranian Chemical Society 2020
Abstract Vildagliptin is a selective, potent drug developed for the treatment of type 2 diabetes mellitus. Lower limb infections in diabetic patients are frequently caused by a mixture of aerobic and anaerobic pathogens which needs the co-administration of antimicrobial agents such as β-lactam/β-lactamase inhibitor combinations and metronidazole for anaerobic pathogens. In the present study, a new gradient HPLC method was developed for the simultaneous separation and quantification of Vildagliptin, Ampicillin, Sulbactam and Metronidazole in pharmaceutical dosage forms and human urine. Chromatographic separation was achieved on Kinetex 2.6 C18 column 100A (4.6 mm × 10 mm) with UV detection at 230 nm. The separation time was about 5 min which allows diminished organic solvent consumption. The method conditions were optimized with respect to different factors. The method was found to be linear, specific, precise and accurate and was compared with other reported methods for single determination of these drugs using student’s t test and F test. The method has the advantage of being rapid, sensitive and also its application to human urine gives the advantage to be used in clinical units for hospitalized patients. This method was used to know the patterns of urinary excretion of Vildagliptin, Ampicillin-sulbactam and Metronidazole by healthy volunteers. Keywords Antimicrobial agents · Vildagliptin · Urinary excretion pattern · Urine
Introduction Vildagliptin (VILD) is (2S)-1-[2-[(3-hydroxy-1 adamantlyl) amino] acetyl] pyrrolidine-2-carbonitrile, Fig. 1. It is a selective, powerful, orally active inhibitor of dipeptidyl peptidase-IV being created for the treatment of type 2 diabetes mellitus. It is reported to be effective and well tolerated in patients with type 2 diabetes mellitus (T2DM) as either Electronic supplementary material The online version of this article (https://doi.org/10.1007/s13738-020-02065-z) contains supplementary material, which is available to authorized users. * Eman A. Abdel Hameed [email protected] 1
Pharmaceutical Analytical Chemistry Department, Faculty of Pharmacy, AL AZHAR University, Assiut, Egypt
2
Pharmaceutical Analytical Chemistry Department, Faculty of Pharmacy, Suez Canal University, Ismailia, Egypt
3
Pharmaceutical Analytical Chemistry Department, Faculty of Pharmacy, Port Said University, Port Said, Egypt
monotherapy or in combination with other antidiabetic medications. Vildagliptin is 20–25% eliminated as unchanged drug in urine within 24 h [1]. Different analytical methods had been proposed for analysis of VILD present in pure form, different pharmaceutical preparations and biological fluids, including, spectrophotometric approaches [2–4
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