Validation of assay method of amlodipine in tablets by liquid chromatography

Authors

  • L. S. Logoyda I. Ya. Horbachevsky Ternopil State Medical University, Ukraine
  • D. B. Korobko I. Ya. Horbachevsky Ternopil State Medical University, Ukraine

DOI:

https://doi.org/10.24959/ubphj.16.86

Keywords:

amlodipine, quantitative analysis, validation, chromatography, validation parameters

Abstract

The aim of this study was the validation of methods of quantitative determination of amlodipine in tablets by liquid chromatography. Methods: The chromatographic analysis was performed on amlodipine liquid chromatograph Agilent 1290 Infinity II LC System. Results: A validation of methods of quantitative determination of amlodipine by high performance liquid chromatography tablets has been 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. Conclusion: The results obtained in this study clearly indicate that the developed HPLC method is fast, economical, simple, accurate and suitable for determination of amlodipine in medications.

References

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.

Денисенко Н. В. Валідація кількісного визначення флуконазолу в капсулах методом рідинної хроматографії / Н. В. Денисенко, Д. А. Леонтьєв, Ю. А. Комарова, О.І. Гризодуб // Фармаком. – 2010. - № 1. - С. 74-84.

Kondratova Y., Adebayo T., Logoyda L., Korobko D., Berdey I., Kuchmerovska T. Development of the methodology of the chromatographic determination of amlodipine in medicines Int. J. Res. Ayurveda Pharm. Jul - Aug 2016; 7(4): 32-35.

Державна Фармакопея України : в 3 т. / Державне підприємство «Український науковий фармакопейний центр якості лікарських засобів». – 2-е вид. – Харків: Державне підприємство «Український науковий фармакопейний центр якості лікарських засобів», 2014. – Т. 2. – 724 с.

Logoyda L. Validation of chromatographic methods of analysis for the determination of active pharmaceutical ingredients in different medicines. PharmaSchool association for pharmaceutical development and scientific research 2016; 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.

Downloads

Published

2016-12-20

Issue

Section

Pharmaceutical chemistry and pharmacognosy