Simultaneous determination of second-generation antihistamines and preservatives in pharmaceutical formulations: A comprehensive multi-metric sustainability of an RP-HPLC method


Sarikaya Yildiz İ., Çağlar Andaç S.

Sustainable Chemistry and Pharmacy, vol.52, 2026 (SCI-Expanded, Scopus) identifier

  • Publication Type: Article / Article
  • Volume: 52
  • Publication Date: 2026
  • Doi Number: 10.1016/j.scp.2026.102458
  • Journal Name: Sustainable Chemistry and Pharmacy
  • Journal Indexes: Science Citation Index Expanded (SCI-EXPANDED), Scopus, BIOSIS, Chemical Abstracts Core, EMBASE
  • Keywords: Green analytical chemistry, Pharmaceutical quality control, Preservatives, Second-generation antihistamines
  • Istanbul University Affiliated: Yes

Abstract

Histamine blockers are widely prescribed as first-line therapies for allergic diseases and rank among the most frequently used medications in developed countries. In this study, an RP-HPLC method was developed and validated for the simultaneous determination of second-generation H1-receptor antagonists (desloratadine, loratadine, and cetirizine) together with commonly used preservatives (methylparaben, propylparaben, and sodium benzoate) in tablets, syrups, and oral drops. The method enables the quantitative determination of both active pharmaceutical ingredients and preservatives in accordance with regulatory requirements.Chromatographic separation was achieved on a Thermo Acclaim C18 column (150 × 4.6 mm, 3.0 μm) using gradient elution with methanol and 0.02 M ammonium acetate buffer (pH 4.4), providing complete separation within 13 min. Method validation performed in accordance with ICH guidelines confirmed specificity, linearity, precision, accuracy, and robustness, with excellent linearity (R2 ≥ 0.998 for all analytes).Given that HPLC remains the most widely used technique in routine pharmaceutical quality control, improving its environmental and practical performance represents an important objective. In this context, the proposed method and selected literature methods were systematically evaluated using a multi-metric assessment framework integrating environmental, analytical, and practical dimensions (EPPI, MA, CACI, and CaFRI). The method enables simultaneous multi-analyte determination within a single analytical procedure, reducing analytical redundancy, solvent consumption, and operational complexity.Overall, this study provides a transparent, comparative, and scalable framework for the evaluation and improvement of RP-HPLC methods in sustainability-oriented pharmaceutical quality control.