Department of Pharmaceutical Analytical Chemistry, Faculty of Pharmacy, Mansoura University, Mansoura 35516, Egypt; Department of Pharmaceutical Analytical Chemistry, Faculty of Pharmacy, Suez Canal University, Egypt.
Department of Pharmaceutical Analytical Chemistry, Faculty of Pharmacy, Mansoura University, Mansoura 35516, Egypt.
Spectrochim Acta A Mol Biomol Spectrosc. 2022 Feb 15;267(Pt 2):120623. doi: 10.1016/j.saa.2021.120623. Epub 2021 Nov 14.
An innovative simple, rapid and sensitive spectrophotometric method was developed for the simultaneous analysis of sofosbuvir (SOF) and ledipasvir (LED) in their combined dosage forms. Sofosbuvir with ledipasvir (SOF/LED) as a combined dosage form was tried at the pandemic COVID 19 crisis. This technique has the advantages of both zero order and first order spectrophotometry. The zero and first derivative amplitudes were measured at 274.2 nm for SOF (zero crossing point of LED in first derivative spectrum) and 314 nm for LED (zero crossing point of SOF in first derivative spectrum) over the concentration range of 2.0-50.0 μg mL with coefficients of determination (R) > 0.9999 for both drugs and mean percentage recoveries of 100.25 ± 1.61 and 99.85 ± 0.99 for SOF and LED; respectively. This original method was validated according to ICH requirements and statistically compared to published comparison methods. This method was applied to estimate the average content and the uniformity of dosage units of SOF/LED combined dosage form according to British Pharmacopeia requirements.
开发了一种新颖、快速和灵敏的分光光度法，用于同时分析联合制剂中的索非布韦（SOF）和来迪派韦（LED）。在 COVID-19 大流行期间，尝试了索非布韦与来迪派韦（SOF/LED）的联合制剂。该技术结合了零阶和一阶分光光度法的优点。在 2.0-50.0μg·mL 的浓度范围内，SOF 的零阶和一阶导数幅度分别在 274.2nm（LED 一阶导数光谱中的零交叉点）和 314nm（SOF 一阶导数光谱中的零交叉点）处测量，两种药物的相关系数（R）均大于 0.9999，SOF 和 LED 的平均回收率分别为 100.25±1.61%和 99.85±0.99%；分别。该方法根据 ICH 要求进行了验证，并与已发表的比较方法进行了统计学比较。根据英国药典的要求，该方法用于估计 SOF/LED 联合制剂的平均含量和单位剂量的均匀度。
