A stability indicating novel analytical method for the determination of lamivudine and dolutegravir in bulk and its tablets using reverse phase high-performance liquid chromatography

IF 0.2 Q4 PHARMACOLOGY & PHARMACY Asian Journal of Pharmaceutical Research and Health Care Pub Date : 2022-10-01 DOI:10.4103/ajprhc.ajprhc_38_22
K. Lalitha, J. Reddy, D. Nayakanti
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Abstract

Aim: A simple and sensitive analytical method was developed to simultaneously estimate lamivudine (LAM) and dolutegravir (DOL), anti-retroviral drug combination in bulk and dosage forms. Materials and Methods: Separation of analytes was done on a BEH Shield RP18 (2.1 mm × 100 mm × 1.7 mm, 5 μm Particle size) using sodium dihydrogen phosphate pH 4.9 adjusted with orthophosphoric acid: Methanol (60:40, %v/v) as mobile phase pumped at 1.0 ml/min. A photodiode array detector was used to find the detection wavelength at an isosbestic point of 292 nm while maintaining the column temperature at 30°C. With a total run period of 8 min, the mobile phase was utilized as a diluent. The International Council on Harmonization guidelines were followed in the method's validation. The method's capacity to indicate stability was confirmed by experiments on forced degradation. Results: LAM and DOL eluted at 2.88 and 3.83 min, respectively. Both the drugs exhibited excellent linearity between 105.00–315.00 and 17.50–52.50 μg/ml for LAM and DOL, respectively. The LOD and LOQ were found to be 4.51 and 15.03 μg/ml for LAM and 5.82 and 19.41 μg/ml for DOL, respectively, which are very minute concentrations. Conclusion: The method was therefore found to be quite sensitive. The proposed high-performance liquid chromatography technique was thereby sensitive, reproducible, accurate, and reliable for the measurement of LAM and DOL.
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建立了反相高效液相色谱法测定拉米夫定和多替格拉韦散装及片剂含量的新方法
目的:建立一种简便、灵敏的同时评价拉米夫定(LAM)和多替格拉韦(DOL)这两种抗逆转录病毒药物组合原料药和剂型的分析方法。材料与方法:在BEH Shield RP18 (2.1 mm × 100 mm × 1.7 mm, 5 μm粒径)上进行分离,以正磷酸:甲醇(60:40,%v/v)为流动相,以1.0 ml/min泵送,pH为4.9。采用光电二极管阵列检测器,在柱温为30℃的条件下,在等吸点292 nm处找到检测波长。流动相作为稀释剂,总运行周期为8 min。该方法的验证遵循了国际协调理事会的准则。通过强迫退化实验验证了该方法的稳定性。结果:LAM和DOL洗脱时间分别为2.88 min和3.83 min。两种药物的LAM和DOL分别在105.00 ~ 315.00和17.50 ~ 52.50 μg/ml范围内呈良好的线性关系。检测结果表明,LAM的LOD和LOQ分别为4.51和15.03 μg/ml, DOL的LOD和LOQ分别为5.82和19.41 μg/ml,均为极微量浓度。结论:该方法具有较高的灵敏度。因此,所建立的高效液相色谱技术对LAM和DOL的测定具有灵敏度高、重复性好、准确性高、可靠性好等特点。
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