A Simple, sensitive, and specific stability indicating reverse phase HPLC method was developed for simultaneous estimation of Lamivudine and Dolutegravir in bulk and tablet dosage form. Effective separation was achieved by injecting10 μL of the standard solution into Xbridge Phenyl (250 × 4.6 mm, 5 μ,100 A0) column, using a mobile phase composition of methanol: buffer (0.1% v/v trifluoroacetic acid in water) (85:15 v/v) and isocratic elution programming have been done at a flow rate of 0.8 mL/min. The eluted analytes detected at 258 nm wavelength. The stress conditions such as acid, base, oxidative, thermal, and photo stability were applied as per ICH guidelines to determine the stability of the drugs in different environmental conditions. The retention times of Lamivudine and Dolutegravir were found to be 3.4 and 5.0 min respectively. The developed method was linear in the concentration range of 5–15 μg/mL and 30–90 μg/mL for Dolutegravir and Lamivudine respectively. Detection and quantification limits were observed at 3.6 and 11 μg/mL for Lamivudine and 0.50 and 1.5 μg/mL for Dolutegravir. Method validation parameters were within the acceptance criteria of ICH guidelines, and the degradation products were well resolved from Dolutegravir and Lamivudine peaks, which indicate the stability of the method. The developed RP-HPLC method was highly precise, specific, sensitive, and stability indicating. Hence, the method has the ability to use in quality control department for regular analysis for the estimation of Lamivudine and Dolutegravir.

中文翻译：

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一种有效的稳定性指示RP-HPLC方法，用于同时估算散装的Dolutegravir和Lamivudine及其片剂剂型

开发了一种简单，灵敏和特异的稳定性指示反相HPLC方法，用于同时估算散装和片剂剂型的拉米夫定和杜鲁格韦。通过使用甲醇：缓冲液（0.1％v / v的三氟乙酸水溶液）的流动相组成，向Xbridge Phenyl（250×4.6 mm，5μ，100 A0）色谱柱中注入10μL标准溶液，实现有效分离：15 v / v）和等度洗脱程序已以0.8 mL / min的流速进行。在258 nm波长处检测到洗脱的分析物。根据ICH指南应用了酸，碱，氧化，热和光稳定性等应激条件，以确定药物在不同环境条件下的稳定性。拉米夫定和Dolutegravir的保留时间分别为3.4和5.0分钟。对于Dolutegravir和Lamivudine，所开发的方法分别在5-15μg/ mL和30-90μg/ mL的浓度范围内呈线性关系。拉米夫定的检测和定量限分别为3.6和11μg/ mL，杜鲁格韦为0.50和1.5μg/ mL。方法验证参数在ICH指南的接受标准之内，并且降解产物已从Dolutegravir和Lamivudine峰中很好地分离，这表明了方法的稳定性。研发的RP-HPLC方法具有很高的精确度，特异性，灵敏性和稳定性。因此，该方法具有在质量控制部门进行常规分析以估计拉米夫定和多洛格韦的能力。拉米夫定的检测和定量限分别为3.6和11μg/ mL，杜鲁格韦为0.50和1.5μg/ mL。方法验证参数在ICH指南的接受标准之内，并且降解产物已从Dolutegravir和Lamivudine峰中很好地分离，这表明该方法的稳定性。所开发的RP-HPLC方法具有很高的精确度，特异性，灵敏性和稳定性。因此，该方法具有在质量控制部门进行常规分析以估计拉米夫定和多洛格韦的能力。拉米夫定的检测和定量限分别为3.6和11μg/ mL，杜鲁格韦为0.50和1.5μg/ mL。方法验证参数在ICH指南的接受标准之内，并且降解产物已从Dolutegravir和Lamivudine峰中很好地分离，这表明了方法的稳定性。研发的RP-HPLC方法具有很高的精确度，特异性，灵敏性和稳定性。因此，该方法具有在质量控制部门进行常规分析以估计拉米夫定和多洛格韦的能力。说明该方法的稳定性。研发的RP-HPLC方法具有很高的精确度，特异性，灵敏性和稳定性。因此，该方法具有在质量控制部门进行常规分析以估计拉米夫定和多洛格韦的能力。说明该方法的稳定性。所开发的RP-HPLC方法具有很高的精确度，特异性，灵敏性和稳定性。因此，该方法具有在质量控制部门进行常规分析以估计拉米夫定和多洛格韦的能力。