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Pharmaceutical Sciences and Drug Design

2022 Volume 2
Creative Commons License

Development and Validation of an RP-HPLC Method for Simultaneous Quantification of Azelnidipine and Metoprolol Succinate in Synthetic Mixtures


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  1. Analytical Development Department, Shenzhen DEC Pharmaceutical Co., Ltd, Shenzhen, 518000, China.
  2. Department of Chemistry, School of Science, GITAM Deemed to be University, Hyderabad, Telangana, 502329, India.
  3. Analytical Research & Development, Hikma Pharmaceuticals USA Inc., Columbus, OHIO, 43064, USA.
Abstract

This study outlines an RP-HPLC technique for quantifying azelnidipine and metoprolol succinate in a synthetic mixture. Azelnidipine, a calcium channel blocker, and metoprolol succinate, a beta-blocker, are both used for the management of hypertension. The method was optimized using a Shimadzu HPLC LC2010 system, equipped with a UV-VIS detector and a binary gradient system. A Hibar ODS C18 5 µm column (250 x 4.6 mm) was used for separation in isocratic mode, with a mobile phase consisting of methanol and water (70:30 v/v, pH 3.0), at a flow rate of 1.0 ml/min and detection set at 230 nm. The method demonstrated linearity for azelnidipine in the range of 8-40 µg/ml and for metoprolol succinate between 25-125 µg/ml. This developed method successfully determined both drugs in synthetic mixtures and followed the ICH Q2 R1 guidelines for method validation.


How to cite this article
Vancouver
Kowtharapu LP, Katari NK, Muchakayala SK, Pydimarry SPR, Rekulapally VK, Sandoval CA. Development and Validation of an RP-HPLC Method for Simultaneous Quantification of Azelnidipine and Metoprolol Succinate in Synthetic Mixtures. Pharm Sci Drug Des. 2022;2:1-7. https://doi.org/10.51847/42JUgzvW13
APA
Kowtharapu, L. P., Katari, N. K., Muchakayala, S. K., Pydimarry, S. P. R., Rekulapally, V. K., & Sandoval, C. A. (2022). Development and Validation of an RP-HPLC Method for Simultaneous Quantification of Azelnidipine and Metoprolol Succinate in Synthetic Mixtures. Pharmaceutical Sciences and Drug Design, 2, 1-7. https://doi.org/10.51847/42JUgzvW13

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