Green RP-HPLC method for impurity profile of amlodipine in tablets

Olga Gigopulu; Hrisanta Godzo; Biljana Atanasovska; Marija Zafirova Gjorgievska; Ana Poceva Panovska; Jasmina Tonic-Ribarska; Jelena Acevska; Katerina Brezovska; Natalija Nakov

doi:10.5937/arhfarm74-49799

Olga Gigopulu Ss. Cyril and Methodius University in Skopje, Faculty of Pharmacy, Institute of Applied Chemistry and Pharmaceutical Analysis
Hrisanta Godzo Ss. Cyril and Methodius University in Skopje, Faculty of Pharmacy, Institute of Applied Chemistry and Pharmaceutical Analysis
Biljana Atanasovska Ss. Cyril and Methodius University in Skopje, Faculty of Pharmacy, Institute of Applied Chemistry and Pharmaceutical Analysis
Marija Zafirova Gjorgievska Ss. Cyril and Methodius University in Skopje, Faculty of Pharmacy, Center for Drug Quality Control
Ana Poceva Panovska Ss. Cyril and Methodius University in Skopje, Faculty of Pharmacy, Institute of Applied Chemistry and Pharmaceutical Analysis
Jasmina Tonic-Ribarska Ss. Cyril and Methodius University in Skopje, Faculty of Pharmacy, Institute of Applied Chemistry and Pharmaceutical Analysis
Jelena Acevska Ss. Cyril and Methodius University in Skopje, Faculty of Pharmacy, Institute of Applied Chemistry and Pharmaceutical Analysis
Katerina Brezovska Ss. Cyril and Methodius University in Skopje, Faculty of Pharmacy, Institute of Applied Chemistry and Pharmaceutical Analysis
Natalija Nakov Ss. Cyril and Methodius University in Skopje, Faculty of Pharmacy, Institute of Applied Chemistry and Pharmaceutical Analysis

DOI: https://doi.org/10.5937/arhfarm74-49799

Keywords: amlodipine, impurity profile, green method, HPLC, greenness evaluation

Abstract

Increased awareness of nature preservation has encouraged the introduction of the green analytical chemistry (GAC) practice concepts concerning several important aspects, including sustainable development, environmental impact, and minimum waste. The aim of this research was to contribute to the implementation of this approach for the pharmaceutical industry while retaining the crucial aspects and strict requirements of quality control of medicines. Therefore, an ethanol-based, green and robust high-performance liquid chromatography (HPLC) method for the determination of related substances of amlodipine (AML) in film-coated tablets was developed and optimized using the Design of Experiments (DoE). The chromatographic separation was performed on an RP-select B column (250 x 4.0 mm, 5 μm), using a mixture of 0.04 M sodium dihydrogen phosphate monohydrate (pH 4.0) and ethanol (60:40 % v/v) as a mobile phase. The optimized conditions provided the separation of two specified impurities (impurity D and impurity F). The selectivity of the method was confirmed using forced degradation studies. The Analytical Eco-scale approach and AGREE metrics confirmed that the method conforms to the GAC principles. The validated method was successfully applied for the determination of related substances in three samples from the market, demonstrating the applicability of the method in routine analysis.

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