Yassin Mohamed G, Roshdy Aya, Marie Aya A
Zeta Pharma for Pharmaceutical Industries, Sadat City, Egypt.
Pharmaceutical Chemistry Department, Faculty of Pharmacy, Horus University, New Damietta, 34517, Egypt.
Sci Rep. 2025 Jan 17;15(1):2281. doi: 10.1038/s41598-025-85776-8.
RP-HPLC technique was developed and optimized for simultaneous identification and estimation of nirmatrelvir (NIR) and ritonavir (RIT) in their new copackaged tablet. Stability of nirmatrelvir (NIR) was studied after exposure to different five stress conditions; alkali, acid, heat, photo and oxidation degradation. The chromatographic separation was achieved using VDSpher PUR 100 ODS (4.6-mm x 15-mm), 3.5 μm column and mixture of 0.03 M potassium di-hydrogen phosphate buffer pH 4 and acetonitrile (45:55, v/v) as mobile phase. The column temperature was set at 40 °C, flow rate at 1mL/min and UV detection at 215 nm. The NIR and RIT retention times were 3.94 ± 0.08 min and 9.08 ± 0.1 min, respectively. Linear relationship was established in range of (1.5-105 µg/mL) for NIR and (1-70 µg/mL) for RIT with good reproducibility. The found mean percentage recoveries of nirmatrelvir (NIR) and ritonavir (RIT) were 100.03% and 99.85%, respectively. The developed method shows very good sensitivity as the LOQ and LOD were found to be 3.001 & 0.990 µg/mL, respectively for NIR and 2.765 & 0.912 µg/mL, respectively for RIT. The developed approach was validated concerning to ICH guidelines and applied successfully for the simultaneous estimation of NIR and RIT in their new copackaged dosage from. The results of assay using the proposed approach were compared statistically to the results found by applying the published one with good agreement.
开发并优化了反相高效液相色谱（RP-HPLC）技术，用于同时鉴定和测定新的复方包装片剂中的奈玛特韦（NIR）和利托那韦（RIT）。在暴露于不同的五种应激条件（碱、酸、热、光和氧化降解）后，研究了奈玛特韦（NIR）的稳定性。使用VDSpher PUR 100 ODS（4.6毫米×15毫米）、3.5μm柱以及0.03M磷酸二氢钾缓冲液pH 4和乙腈（45:55，v/v）的混合物作为流动相进行色谱分离。柱温设定为40°C，流速为1mL/min，紫外检测波长为215nm。NIR和RIT的保留时间分别为3.94±0.08分钟和9.08±0.1分钟。在（1.5-105μg/mL）范围内建立了NIR的线性关系，在（1-70μg/mL）范围内建立了RIT的线性关系，具有良好的重现性。奈玛特韦（NIR）和利托那韦（RIT）的平均回收率分别为100.03%和99.85%。所开发的方法显示出非常好的灵敏度，因为NIR的定量限（LOQ）和检测限（LOD）分别为3.001和0.990μg/mL，RIT的定量限和检测限分别为2.765和0.912μg/mL。所开发的方法根据国际协调会议（ICH）指南进行了验证，并成功应用于同时测定新复方包装剂型中的NIR和RIT。将使用所提出方法的含量测定结果与应用已发表方法得到的结果进行统计学比较，结果吻合良好。
