Department of Chemistry, GITAM University, Visakhapatnam, Andhra Pradesh, India.
Institute of Science and Technology, JNTU, Hyderabad, Telangana, India.
Biomed Chromatogr. 2021 Aug;35(8):e5121. doi: 10.1002/bmc.5121. Epub 2021 Apr 18.
A novel method was developed for the simultaneous estimation of the doravirine, lamivudine, and tenofovir disoproxil fumarate in the pharmaceutical dosage form. The chromatogram was run through an Ascentis C18 column (150 × 4.6 mm, 2.7 μm), with the mobile phase consisting of a phosphate buffer and acetonitrile in the ratio of 50:50 (v/v). The mobile phase was pumped through the column at a flow rate of 1 mL/min. The column temperature was maintained at 30°C. The optimized wavelength for doravirine, lamivudine, and tenofovir disoproxil fumarate was 230.0 nm. The retention times for doravirine, lamivudine, and tenofovir disoproxil were 2.222, 2.764, and 3.403 min, respectively; the relative standard deviation (%) values of method precision for doravirine, lamivudine, and tenofovir disoproxil were 0.6, 0.6, and 0.1, respectively. The % recovery was 100.20%, 100.15%, and 100.36% for doravirine, lamivudine, and tenofovir disoproxil fumarate, respectively. The limit of detection and limit of quantification values were obtained from regression equations of doravirine, lamivudine, and tenofovir disoproxil fumarate, and were 0.24 and 0.73 ppm, 0.53 and 1.60 ppm, and 0.47 and 1.43 ppm, respectively. The regression equations of doravirine, lamivudine, and tenofovir disoproxil fumarate were y = 17,541x + 117,303, y = 15,555x + 10,791, and y = 15,250x + 31,663, respectively. The method developed was accurate, simple, precise, sensitive, and economical. Hence, it could be adopted for regular quality control for estimation of doravirine, lamivudine, and tenofovir disoproxil fumarate in pharmaceutical industries.
开发了一种同时测定药物制剂中多伟伦、拉米夫定和替诺福韦二吡呋酯的新方法。色谱在 Ascentis C18 柱（150×4.6mm，2.7μm）上运行，流动相由磷酸盐缓冲液和乙腈以 50:50（v/v）的比例组成。流动相以 1mL/min 的流速泵入柱中。柱温保持在 30°C。多伟伦、拉米夫定和替诺福韦二吡呋酯的优化波长为 230.0nm。多伟伦、拉米夫定和替诺福韦二吡呋酯的保留时间分别为 2.222、2.764 和 3.403min；多伟伦、拉米夫定和替诺福韦二吡呋酯的方法精密度（%）相对标准偏差（RSD）值分别为 0.6、0.6 和 0.1。多伟伦、拉米夫定和替诺福韦二吡呋酯的回收率分别为 100.20%、100.15%和 100.36%。多伟伦、拉米夫定和替诺福韦二吡呋酯的检测限和定量限分别通过多伟伦、拉米夫定和替诺福韦二吡呋酯的回归方程获得，为 0.24 和 0.73ppm、0.53 和 1.60ppm 以及 0.47 和 1.43ppm。多伟伦、拉米夫定和替诺福韦二吡呋酯的回归方程分别为 y=17541x+117303、y=15555x+10791 和 y=15250x+31663。所开发的方法准确、简单、精确、灵敏且经济。因此，它可以被采用用于药物制剂中多伟伦、拉米夫定和替诺福韦二吡呋酯的常规质量控制。
