A new simple, precise and robust isocratic reverse-phase high performance liquid chromatography (RP-HPLC) method was developed and validated for simultaneous determination of lamivudine, tenofovir disoproxil fumarate (TDF), and doravirine in bulk and pharmaceutical dosage form. The validation included specificity, linearity, system suitability, precision, robustness, LOD and LOQ characteristics. The chromatographic separation was achieved on C 18 X bridge phenyl column (150 × 4.6 mm, 3 μm particle size) eluted with acetonitrile and hexane-1-sulfonic acid (pH 2.5; 50:50, v/v) at a flow rate of 0.8 mL/min and monitored at 243 nm over a run time of 12 min. The retention times of lamivudine, TDF, and doravirine were found to be 2.45, 7.3, and 8.79 min. respectively. The method was linear in the range of 5 – 100 μg/mL ( r 2 = 0.999) for lamivudine and TDF and in the range of 1.75 – 35 μg/mL ( r 2 = 0.999) for doravirine. The percentage recoveries of three drugs were within the acceptable limits (98 – 102%). The method was found to be precise as confirmed by % RSD < 0.6. Forced degradation study was conducted as per ICH guidelines, and the three drugs showed degradation within 21.4 – 33.8% under acidic, basic, oxidative, photolysis, and hydrolysis conditions. The proposed RP-HPLC method can be used for the quantification of lamivudine, TDF, and doravirine in API and tablets without any interference from excipients.

中文翻译：

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通过液相色谱和二极管阵列检测同时定量药物剂型中的拉米夫定、富马酸替诺福韦二吡呋酯和多拉韦林

开发并验证了一种新的简单、精确和稳定的等度反相高效液相色谱 (RP-HPLC) 方法，用于同时测定散装和药物剂型中的拉米夫定、富马酸替诺福韦二吡呋酯 (TDF) 和多拉韦林。验证包括特异性、线性、系统适用性、精密度、稳健性、LOD 和 LOQ 特性。在 C 18 X 桥苯基柱（150 × 4.6 mm，3 μm 粒径）上实现色谱分离，用乙腈和己烷-1-磺酸（pH 2.5；50:50，v/v）洗脱，流速为0.8 mL/min 并在 243 nm 处监测，运行时间为 12 分钟。拉米夫定、TDF 和多拉韦林的保留时间分别为 2.45、7.3 和 8.79 分钟。分别。该方法在 5 – 100 μg/mL ( r 2 = 0. 999) 拉米夫定和 TDF，多拉韦林的范围为 1.75 – 35 μg/mL (r 2 = 0.999)。三种药物的回收率均在可接受的范围内 (98 – 102%)。% RSD < 0.6 证实了该方法是精确的。根据 ICH 指南进行强制降解研究，三种药物在酸性、碱性、氧化、光解和水解条件下的降解率在 21.4-33.8% 之间。建议的 RP-HPLC 方法可用于定量 API 和片剂中的拉米夫定、TDF 和多拉韦林，而不受赋形剂的任何干扰。根据 ICH 指南进行强制降解研究，三种药物在酸性、碱性、氧化、光解和水解条件下的降解率在 21.4-33.8% 之间。建议的 RP-HPLC 方法可用于定量 API 和片剂中的拉米夫定、TDF 和多拉韦林，而不受赋形剂的任何干扰。根据 ICH 指南进行强制降解研究，三种药物在酸性、碱性、氧化、光解和水解条件下的降解率在 21.4-33.8% 之间。建议的 RP-HPLC 方法可用于定量 API 和片剂中的拉米夫定、TDF 和多拉韦林，而不受赋形剂的任何干扰。