PhD Scientific Days 2026

Poster Session 3.H - Pharmaceutical Sciences and Health Technologies

Sustainable HPLC Enantioseparation of Rosuvastatin and Atorvastatin

Előadó neve

Tóth, Eliza

Neptune code

S5S80M

Előadó munkahelye

Department of Pharmaceutical Chemistry, Semmelweis University, Budapest, Hungary

Előadó telefonszáma

+36204105354

Előadó e-mail címe

toth.eliza@phd.semmelweis.hu

Az előadás címe

Sustainable HPLC Enantioseparation of Rosuvastatin and Atorvastatin

Szerző(k) neve és munkahelye

Eliza Tóth¹, Ali Mhammad¹, Gergely Dombi¹, Gergő Tóth¹

1: Department of Pharmaceutical Chemistry, Semmelweis University, Budapest, Hungary

Bemutatás módja

Poszter

Szekció

Poster Session 3.H - Pharmaceutical Sciences and Health Technologies

Language of the presentation

English

Preferred session

Pharmaceutical Sciences and Health Technologies

Összefoglaló szövege

Introduction
Rosuvastatin and atorvastatin are chiral statins whose stereochemical purity must be rigorously controlled in line with the growing emphasis on green analytical methodologies.
Aims
Our aim was to develop and validate environmentally improved HPLC methods for the enantioseparation of rosuvastatin and atorvastatin using polysaccharide-based chiral stationary phases and green chemistry metrics.
Methods
The enantioselective performance of several polysaccharide-based chiral stationary phases was systematically examined under polar organic and reversed-phase conditions, identifying Lux Cellulose-3 as the most suitable phase. The final rosuvastatin method used acetonitrile:water (25:75, v/v) containing 0.03% phosphoric acid, a flow rate of 1 mL/min, a column temperature of 40 °C, and a run time of 10 min, whereas the atorvastatin method employed acetonitrile:water (25:75, v/v) containing 0.07% phosphoric acid, a flow rate of 1 mL/min, a column temperature of 45 °C, and a run time of 30 min. Both methods were validated according to ICH requirements.
Results
The rosuvastatin and atorvastatin methods achieved resolutions of 1.54 and 1.83, respectively, with excellent linearity (r² ≥ 0.9996), precision (RSD ≤ 2%), and accuracy of approximately 98-101%. Evaluation using AGREE and RGBfast showed AGREE scores of 0.54 for rosuvastatin and 0.53 for atorvastatin, both higher than those of the corresponding pharmacopoeial procedures (0.45 and 0.42, respectively), while RGBfast confirmed improved whiteness for both newly developed methods.
Conclusion
Lux Cellulose-3-based HPLC methods provide robust, fully validated, and environmentally superior enantioseparations of rosuvastatin and atorvastatin, making them suitable for routine pharmaceutical quality control within a green analytical chemistry framework.

Funding
Supported by the 2025-2.1.1-EKÖP-2025-00014 (G.D.) and 2025-2.1.2-EKÖP-KDP (E.T.) University Research Scholarship Programmes of the Ministry for Culture and Innovation from the National Research, Development and Innovation Fund. This work was also funded by the National Research, Development, and Innovation Office, Hungary (grant: NKFIH FK 146930 and by the János Bolyai Research Scholarship of the Hungarian Academy of Sciences (G.T).

University

Semmelweis University

Supervisor

Gergő Tóth

Publication of my abstract

I do not give consent to the publication of my abstract on the website of the congress.

phd.section.field

in doctoral studies before complex exam (PhD)

Kind

Szabad

Status

elfogadva

Accepted presentation method

poszter

Előadás fájl jóváhagyás

nem rendelkezett róla

Előadó

9813

Start

13:54

End

13:57