Gadepalli Shankar Ganesh, Deme Pragney, Kuncha Madhusudana, Sistla Ramakrishna
Pharmacology Division, Indian Institute of Chemical Technology, Tarnaka, Hyderabad, Andhra Pradesh 500007, India.
National Center for Mass Spectrometry, Indian Institute of Chemical Technology, Tarnaka, Hyderabad, Andhra Pradesh 500007, India.
J Pharm Anal. 2014 Dec;4(6):399-406. doi: 10.1016/j.jpha.2013.12.003. Epub 2013 Dec 19.
Polypill is a fixed-dose combination that contains three or more active ingredients used as a single daily pill to achieve a large effect in preventing cardiovascular disease with minimal adverse effects. A novel and accurate liquid chromatography tandem mass spectrometry method using electrospray ionization mode has been developed and validated for the simultaneous determination of amlodipine (AMD), valsartan (VAL) using losartan (LOS) as an internal standard (IS), and hydrochlorothiazide (HCT) using furosemide (FSD) as an IS. The separation was carried on Aquasil C (50 mm×2.1 mm, 5 µm) reversed phase column using acetonitrile and water containing 0.1% formic acid (50:50, v/v) as the mobile phase. The method was validated in terms of linearity, accuracy and precision over the concentration range of 1-1000 ng/mL. The intra and inter-day precision and accuracy, stability and extraction recoveries of all the analytes were in the acceptable range. This method can be successfully applied to the pharmacokinetic study of AMD, VAL and HCT when given as a polypill.
多效药丸是一种固定剂量的复方制剂，含有三种或更多活性成分，制成每日服用一次的单一药丸，以在预防心血管疾病方面产生显著效果，同时副作用最小。已开发并验证了一种新颖且准确的液相色谱串联质谱法，该方法采用电喷雾电离模式，以氯沙坦（LOS）作为内标（IS）同时测定氨氯地平（AMD）、缬沙坦（VAL），以呋塞米（FSD）作为IS同时测定氢氯噻嗪（HCT）。分离在Aquasil C（50 mm×2.1 mm，5 µm）反相柱上进行，使用含0.1%甲酸的乙腈和水（50:50，v/v）作为流动相。该方法在1 - 1000 ng/mL的浓度范围内进行了线性、准确度和精密度验证。所有分析物的日内和日间精密度与准确度、稳定性及提取回收率均在可接受范围内。该方法可成功应用于多效药丸形式给药时AMD、VAL和HCT的药代动力学研究。
