Alqahtani Saud, Alqahtani Ali, Alqahtani Taha, Almrasy Ahmed A
Department of Pharmacology, College of Pharmacy, King Khalid University, Abha, Saudi Arabia.
Pharmaceutical Analytical Chemistry Department, Faculty of Pharmacy, Al-Azhar University, Cairo, Egypt.
Luminescence. 2025 Aug;40(8):e70280. doi: 10.1002/bio.70280.
This study presents a validated analytical method for the simultaneous determination of olmesartan and rosuvastatin using synchronous spectrofluorimetry integrated with advanced chemometric modeling. The method addresses the limitations of conventional approaches by combining the firefly algorithm (FA) with partial least squares (PLS) regression to overcome spectral overlap challenges. Experimental conditions were optimized, with ethanol as solvent and 0.05% w/v SDS as fluorescence enhancer, achieving a 1.6- and 1.4-fold increase in sensitivity for olmesartan and rosuvastatin, respectively. The FA-PLS approach demonstrated superior performance over conventional PLS, requiring fewer latent variables (2 vs. 4) while achieving lower detection limits in the ng/mL range, markedly tighter residual distributions (±2%), and improved prediction accuracy (RRMSEP: 1.34 and 1.40). The method was successfully validated according to ICH guidelines and applied to pharmaceutical formulations and plasma samples, yielding recoveries of 99.87 ± 1.02% and 99.68 ± 0.56% for olmesartan and rosuvastatin, respectively. Statistical comparison with the reported HPLC method confirmed method equivalence through t-tests, F-tests, and interval hypothesis testing. Environmental impact assessment using AGREE (0.75) and BAGI (75.0) indices demonstrated superior greenness compared to the conventional HPLC method while maintaining excellent analytical practicality, establishing this method as a sustainable alternative for routine pharmaceutical analysis and biomedical applications.
本研究提出了一种经过验证的分析方法，用于使用同步荧光光谱法结合先进的化学计量学模型同时测定奥美沙坦和瑞舒伐他汀。该方法通过将萤火虫算法（FA）与偏最小二乘法（PLS）回归相结合来解决传统方法的局限性，以克服光谱重叠挑战。优化了实验条件，以乙醇为溶剂，0.05% w/v十二烷基硫酸钠作为荧光增强剂，使奥美沙坦和瑞舒伐他汀的灵敏度分别提高了1.6倍和1.4倍。FA-PLS方法显示出优于传统PLS的性能，所需的潜在变量更少（2个对4个），同时在ng/mL范围内实现了更低的检测限、明显更紧密的残差分布（±2%）以及更高的预测准确性（RRMSEP：1.34和1.40）。该方法已根据ICH指南成功验证，并应用于药物制剂和血浆样品，奥美沙坦和瑞舒伐他汀的回收率分别为99.87±1.02%和99.68±0.56%。与报道的HPLC方法进行统计比较，通过t检验、F检验和区间假设检验证实了方法的等效性。使用AGREE（0.75）和BAGI（75.0）指数进行的环境影响评估表明，与传统HPLC方法相比，该方法具有更高的绿色度，同时保持了出色的分析实用性，确立了该方法作为常规药物分析和生物医学应用的可持续替代方法。
