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Analytical method development and validation of Ramipril and Candesartan Cilexetil in synthetic mixture

Volume No : (2020) Volume: 08 Issue : 38 Year : 2020 Page No: 14-20

Authors : Akhil Nagar, Sumit Deore, Atul Bendale, Rajanikant Kakade, Chetankumar Sonawane

Abstract :

Aim: The aim of the study was to develop a rapid, accurate, and precise ratio spectra derivative   spectroscopic high-performance liquid chromatography method and validated for the estimation of  Ramipril (RAM) and Candesartan cilexetil (CAN) in synthetic mixture.
Materials and Methods: The  estimation of RAM, CAN (6 µg/ml) was used as a devisor and for the estimation of CAN, RAM  (5 µg/ml) used as a devisor. The wavelengths selected for quantitative estimation were 331 nm for  RAM and 231 nm and for CAN.

Results: The result for validation shows that linearity of the developed  method was 0.9976 and 0.9994 in the range of 5–10 µg/ml and 6–16 µg/ml for RAM and CAN,  respectively. Phenomenex C18 column (250 mm×4.6 mm, 5 µm particle size) column was used.  Acetonitrile:water (0.5% TEA, pH 4.5 adjusted with 10% orthophosphoric acid) (85:15 v/v) as a  mobile phase, flow rate 1 ml/min and detection carried out at 220 nm. The retention time of RAM  and CAN was 3.607 and 5.613 min, respectively. Linearity of the developed method was found to  be 0.9956 and 0.9974 in the range of 0.5–0.9 µg/ml and 1.60–2.88 µg/ml for RAM and CAN,  respectively.

Conclusion: From the mentioned results, we can conclude that the developed methods  were validated successfully as per the ICH guideline and are accurate, robust, and precise.

Keywords: Candesartan cilexetil, high-performance liquid chromatography, ramipril, simultaneous  estimation, validation

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