University Institute of Pharmacy, Pt. Ravishankar Shukla University, Raipur, Chhattishgarh, 492010, India.
University Institute of Pharmacy, Pt. Ravishankar Shukla University, Raipur, Chhattishgarh, 492010, India.
Spectrochim Acta A Mol Biomol Spectrosc. 2017 Jan 15;171:369-375. doi: 10.1016/j.saa.2016.08.028. Epub 2016 Aug 20.
Three multivariate calibration spectrophotometric methods were developed for simultaneous estimation of Paracetamol (PARA), Enalapril maleate (ENM) and Hydrochlorothiazide (HCTZ) in tablet dosage form; namely multi-linear regression calibration (MLRC), trilinear regression calibration method (TLRC) and classical least square (CLS) method. The selectivity of the proposed methods were studied by analyzing the laboratory prepared ternary mixture and successfully applied in their combined dosage form. The proposed methods were validated as per ICH guidelines and good accuracy; precision and specificity were confirmed within the concentration range of 5-35μgmL, 5-40μgmL and 5-40μgmLof PARA, HCTZ and ENM, respectively. The results were statistically compared with reported HPLC method. Thus, the proposed methods can be effectively useful for the routine quality control analysis of these drugs in commercial tablet dosage form.
建立了三种多元校正分光光度法，用于同时测定片剂中对乙酰氨基酚（PARA）、马来酸依那普利（ENM）和氢氯噻嗪（HCTZ）的含量；即多元线性回归校正（MLRC）、三线性回归校正法（TLRC）和经典最小二乘法（CLS）。通过分析实验室制备的三元混合物研究了所提出方法的选择性，并成功将其应用于它们的组合剂型中。所提出的方法按照 ICH 指南进行了验证，具有良好的准确性；在 5-35μgmL、5-40μgmL 和 5-40μgmL 的 PARA、HCTZ 和 ENM 浓度范围内，证实了精密度和特异性。结果与报道的 HPLC 方法进行了统计学比较。因此，所提出的方法可有效用于这些药物在商业片剂剂型中的常规质量控制分析。
