Bachri Muchlisyam, Masfria Masfria, Syahputra Syahputra, Hafid Hafid
Department of Pharmaceutical Chemistry, Faculty of Pharmacy, Universitas Sumatera Utara, Medan-20155, Indonesia.
Open Access Maced J Med Sci. 2019 Aug 30;7(17):2940-2946. doi: 10.3889/oamjms.2019.750. eCollection 2019 Sep 15.
Irbesartan and hydrochlorothiazide are a group of anti-hypertensive drugs that are very effective and safe to use to reduce blood pressure and oedema. The combination has a small active ingredient content so that if the treatment didn't meet the requirements for therapeutic doses, it not achieved to the maximum therapy.
The research aims to the simultaneous determination of irbesartan and hydrochlorothiazide in tablets by Ratio subtraction spectrophotometry method.
The absorption spectra and sample measurement in the Ratio subtraction method performed on Irbesartan at a wavelength of 247.6 nm and 273.6 nm for the Hydrochlorothiazide (HCT) using 0.1 N NaOH as a solution. This method is validated with linearity, accuracy, and precision in intraday and interday, LOD and LOQ and applied in the determination of a mixture of irbesartan and hydrochlorothiazide in the dosage tablet.
The validation test for IRB is 101.03 for accuracy, with a precision of 0.57; with precision testing at intraday 0.34 and interday 1.34, and LOD is 0.70 and LOQ is 2.12. Meanwhile, validation for HCT that the accuracy 100.34%; precision 0.89 and precision on intraday 1.20 and interday 1.18, and LOD 0.78 and LOQ 2.37 with IRB levels are 101.03 ± 0.63% and HCT is 100.59 ± 0.91%.
The ultraviolet spectrophotometric method in subtraction ratio method was validated a method of linearity, accuracy, precision in intraday and interday, LOD, and LOQ and according to ICH guidelines and successfully applied for the determination simultaneous of irbesartan and hydrochlorothiazide in the tablet's dosage form.
厄贝沙坦和氢氯噻嗪是一组抗高血压药物，用于降低血压和水肿非常有效且安全。该组合的活性成分含量低，因此如果治疗未达到治疗剂量要求，则无法实现最大疗效。
本研究旨在采用比率减法分光光度法同时测定片剂中的厄贝沙坦和氢氯噻嗪。
采用比率减法在波长247.6 nm处对厄贝沙坦进行吸收光谱和样品测定，以0.1 N NaOH溶液为溶剂，在波长273.6 nm处对氢氯噻嗪（HCT）进行测定。该方法通过日内和日间的线性、准确度和精密度、检测限和定量限进行验证，并应用于测定片剂剂型中厄贝沙坦和氢氯噻嗪的混合物。
厄贝沙坦的验证试验准确度为101.03，精密度为0.57；日内精密度试验为0.34，日间为1.34，检测限为0.70，定量限为2.12。同时，氢氯噻嗪的验证结果为准确度100.34%；精密度0.89，日内精密度1.20，日间精密度1.18，检测限0.78，定量限2.37，厄贝沙坦水平为101.03±0.63%，氢氯噻嗪为100.59±0.91%。
比率减法紫外分光光度法经线性、准确度、日内和日间精密度、检测限和定量限验证，符合ICH指南要求，并成功应用于片剂剂型中厄贝沙坦和氢氯噻嗪的同时测定。
