Romanian Society of Pharmaceutical Sciences

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DEVELOPMENT AND VALIDATION OF A NOVEL STABILITY-INDICATING RP-HPLC METHOD FOR THE SIMULTANEOUS QUANTITATION OF AMLODIPINE, GLIMEPIRIDE AND PERINDOPRIL ARGININE

SHADY AWWAD 1*, SAMAR THIAB 1, REEM ISSA 2, HASSAN ABUL-FUTOUH 3, LAITH MH AL-SHDIFAT 1, AHMAD ALJABERI 4, ASAAD SHAHIN 5, DIMA ALBALS 6, BEISAN MOHAMMAD 7, MAHMOUD ABU-SAMAK 8

1 Department of Pharmaceutical Chemistry and Pharmacognosy, Faculty of Pharmacy, Applied Science Private University, Amman 11937, Jordan
2 Department of Basic Pharmaceutical Sciences, Faculty of Pharmacy, Middle East University, Amman, Jordan, Jordan
3 Department of Chemistry, Faculty of Science, The Hashemite University, Zarqa 13133, Jordan
4 Department of Pharmaceutical Sciences and Pharmaceutics, Applied Science Private University, Amman, Jordan
5 Jordan Sweden Medical and Sterilization Company (Joswe-medical), Amman, Jordan
6 Department of Medicinal Chemistry and Pharmacognosy, Faculty of Pharmacy, Yarmouk University, Irbid, Jordan
7 Pharmaceutical Sciences Department-PharmD Program, Fakeeh College for Medical Sciences, Jeddah 21461, Saudi Arabia
8 Department of Clinical Pharmacy and Therapeutics, Applied Science Private University, Amman, Jordan

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An accurate, precise, simple and stability-indicating RP-HPLC method was developed and validated for the simultaneous quantitation of perindopril arginine (PA), amlodipine (AML) and glimepiride (GLM) in solution in accordance with the International Conference on Harmonisation (ICH) guidelines. The HPLC analysis was performed using a Supelcosil LC-18 column (25 cm × 4 mm × 5 μm), at a flow rate of 1.0 mL/min, with wavelength of detection at 220.0 nm for PA, AML and GLM. The optimised mobile phase consisted of a mixture of acetonitrile, methanol and phosphate buffer in the ratio of (20:50:30) (v/v/v) which was adjusted to pH 3.5 ± 0.1 with o-phosphoric acid. The proposed method was validated for linearity, system suitability, accuracy, precision (intra- and inter-day) and robustness. The HPLC results displayed good separation and resolution in a total analysis time of 16 minutes where PA, AML and GLM were eluted at retention times of 4.408 min, 5.415 min and 12.189 min, respectively. The optimised method displayed good linearity over the concentration range of 0.25 - 2.00 mg/mL for PA and 0.10 - 0.75 μg/mL for AML and GLM. The recoveries ranged from 98.0 to 102.0% and the RSD% values were found to be less than 2.00 for all drugs. The combination of three drugs was exposed to several forced degradation studies such as acid, base, neutral, thermal, oxidative and photolytic conditions. The forced degradation studies indicated that the optimised method is valid for stability studies.