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Bioanalytical Method Development and Validation For Simultaneous Estimation of Vildagliptin & Enalapril Maleate In Rabbit Plasma (K2 EDTA) Using Rp-HPLC
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| Author:
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B.KISHORE REDDY, KOTHAPALLI BONNOTH CHANDRA SEKHAR, KRISHNA MOHAN CHINNALA
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| Abstract:
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The aim of this study was develop a simple, rapid and accurate method based on RP-HPLC method was developed to
simultaneous estimation of Vildagliptin and Enalapril Maleate using Tolbutamide as an internal
standard. Chromatography was achieved on Waters C18 (4.6 x 150mm, 5µm) at ambient temperature, effluent was
monitored at 270 nm. Samples were chromatographed in a isocratic mode 25mM Potassium dihydrogen
orthophosphate buffer (pH 6.5): Acetronitrile (60:40 V/V) proportions. The flow rate of mobile phase was1.000
ml/min. Both analytes and ISTD samples were extracted by liquid-liquid extraction technique.: The complete
chromatographic run time was 7.0 minutes and the retention time of Enalapril Maleate, Vildagliptin and IS was attained
at 1.25 min 2.04 and 5.89 min, respectively. A linear response was established at 100-1500 µg/mL for Vildagliptin and
25-200 µg/mL for Enalapril Maleate in rabbit plasma. The between-run coefficients of variation ranged between 0.6%
and 9.8% for Vildagliptin and 2.87% and 10.8% for Enalapril Maleate respectively. The global Recovery for Vildagliptin
was 72.43 and 69.87 for Enalapril Maleate respectively. The method also had good stability. A selective, highly specific,
reproducible, rapid method was developed and also validated to quantify the simultaneous drugs in rabbit plasma as
per the regulatory guidelines. All the parameters and results were within the acceptance limit as given within the
validation protocol. This method uses less biological material conjointly and the technique is MS compatible also. This
method is applicable for pharmacokinetic studies using HPLC or LC-MS.
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| Keyword:
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RP-HPLC, Vildagliptin, Enalapril Maleate, Tolbutamide, Rabbit plasma, Validation.
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| EOI:
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| DOI:
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https://doi.org/10.31838/ijpr/2020.12.01.033
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| Download:
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