Biswal Sabyasachi, Mondal Sumanta, Mondal Prasenjit
Institute of Pharmacy, GITAM (Deemed to be University), Visakhapatnam, Andhra Pradesh, India.
Vaageswari Institute of Pharmaceutical Science, Karimnagar, Telangana, India.
J Pharm Bioallied Sci. 2021 Jan-Mar;13(1):69-75. doi: 10.4103/jpbs.JPBS_337_19. Epub 2020 Dec 21.
The aim of this study was to develop and validate a novel ultra-performance liquid chromatographic method for estimation of darunavir in a bulk and tablet dosage form.
The chromatographic separation was achieved using DIKMA Endoversil (2.1mm x 50mm, 1.7 µm) column. A mixture of 40% buffer (0.1% octa sulfonic acid) and 60% acetonitrile was used as a mobile phase with the isocratic elution mode and eluent was monitored at 281nm using UV detector. The method was continued and validated in accordance with International Conference on Harmonization Guidelines. Validation study revealed the specificity and reliability of the method.
In this method, darunavir was eluted with retention time of 0.516 min. Calibration curve plots were found linear over the concentration ranges 10-50 μg/mL for darunavir. Limit of detection was 0.02 μg/mL and limit of quantification was found 0.07 μg/mL. The present method was also found stable in force degradation study.
The empirical evidences of all the study results revealed the suitability of the estimation of darunavir in bulk and tablet dosage form without any interference from the excipients.
本研究旨在开发并验证一种用于测定原料药及片剂剂型中达芦那韦的新型超高效液相色谱法。
采用迪马科技的Endoversil（2.1mm×50mm，1.7μm）色谱柱进行色谱分离。以40%缓冲液（0.1%八磺酸）和60%乙腈的混合物作为流动相，采用等度洗脱模式，使用紫外检测器在281nm波长处监测洗脱液。该方法按照国际协调会议指南进行持续研究和验证。验证研究表明了该方法的特异性和可靠性。
在该方法中，达芦那韦的保留时间为0.516分钟。校准曲线在达芦那韦浓度范围10 - 50μg/mL内呈线性。检测限为0.02μg/mL，定量限为0.07μg/mL。在强制降解研究中还发现本方法稳定。
所有研究结果的实验证据表明，该方法适用于测定原料药及片剂剂型中的达芦那韦，且不受辅料干扰。
