Validation of assay method of nifedipine in tablets by liquid chromatography
DOI:
https://doi.org/10.11603/mcch.2410-681X.2016.v0.i4.7267Keywords:
nifedipine, quantitative analysis, validation, chromatography, validation parameters.Abstract
The aim of this study was the validation of methods of quantitative determination of nifedipine in tablets by liquid chromatography. The chromatographic analysis was performed on nifedipine liquid chromatograph Agilent 1290 Infinity II LC System. A validation of methods of quantitative determination of nifedipine by high performance liquid chromatography tablets was performed. It was established that the method proves the requirements of the State Pharmacopoeia of Ukraine for the main validation parameters: specificity, accuracy, linearity, robasnist. The results obtained in this study clearly indicate that the developed HPLC method is fast, economical, simple, accurate and suitable for determination of nifedipine in medicines.
References
Derzhavna Farmakopeia Ukrainy : v 3 t. / Derzhavne pidpryiemstvo “Ukrainskyi naukovyi farmakopeinyi tsentr yakosti likarskykh zasobiv”. – 2-he vyd. – Kharkiv : Derzhavne pidpryiemstvo “Ukrainskyi naukovyi farmakopeinyi tsentr yakosti likarskykh zasobiv”, 2014. – T. 2. – 724 s.
Logoyda L. Development and validation of new methods of analysis for the determination of different natural and synthetic original active pharmaceutical ingredients in medicines. Duphat 2015;48.
Grizodub A. I. Standartnye protcedury validatcii metodik kontrolia kachestva lekarstvennykh sredstv / A. I. Grizodub // Farmakom. – 2006. – № 1–2. – S. 35–44.
Logoyda L. Validation of chromatographic methods of analysis for the determination of active pharmaceutical ingredients in different medicines / L. Logoyda // Pharma School association for pharmaceutical development and scientific research 2016. – P. 34.
ICH Topic Q2 (R1) Validation of Analytical Procedures: Text and methodology.
ICH, Q3B validation of analytical procedures: Methodology, international conference on harmonization, Nov, 1996.
