Development and Validation of SI/RS-UHPLC-PDA Method for Olmesartan Medoxomil and Metoprolol Succinate-Related Substance

Thakker, Nirmal; Shinde, Gajanan; Choudhari, Vishnu P.; Dharamsi, Abhay

doi:10.4274/tjps.galenos.2022.57384

Cited by 1 publication

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“…This decreases the work pressure of the heart and reduces pain in the chest [ 5 ]. Analytical procedures are well documented in the literature for the analysis of MET, TEL, and AML alone and along with other drugs [ 6 , 7 , 8 , 9 , 10 , 11 , 12 , 13 ]. The literature documented the implementation of the HPLC technique [ 14 ] for the quantification of AML along with its impurities in formulation.…”

Section: Introductionmentioning

confidence: 99%

Design of Experimental Approach for Development of Rapid High Performance Liquid Chromatographic Process for Simultaneous Estimation of Metoprolol, Telmisartan, and Amlodipine from Formulation: Greenness and Whiteness Evaluation

Attimarad,

Alali,

Alali

et al. 2024

Molecules

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The design of an experimental approach, the Box–Behnken design, was implemented to optimize the chromatographic condition to develop a rapid HPLC procedure for quantification of a ternary mixture of metoprolol (MET), telmisartan (TEL), and amlodipine (AML) from the formulation. The perturbation plots, contour, and 3D response surface pictures were developed to study the impact of each variable on the analytes’ retention time and the probable interaction between the parameters with fewer chromatographic runs. The optimized HPLC method separated the three analytes within 5 min with excellent selectivity and peak shape on a Zorbax C18 HPLC column using acetonitrile and phosphate buffer (20 mM, pH 5.8) with isocratic elution at a 1.1 mL/min flowrate. A wavelength 230 nm was utilized to monitor the elute. The validation of proposed method demonstrated a wide linearity range of 10–200 µg/mL for MET and TEL and 5–50 µg/mL for AML along with an excellent correlation coefficient. The correctness of the HPLC approach was further confirmed by excellent recovery of the added amount of analytes utilizing the standard addition technique. The recommended HPLC approach was employed safely for quality assurance of the formulation, because the evaluation of the method’s greenness and whiteness confirmed the environmentally friendly nature of the approach.

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