Robustness evaluation of the chromatographic determination of nifedipine in pharmaceuticals

L. S. Logoyda

Abstract


Topicality. Robustness tests were originally introduced to avoid problems in interlaboratory studies and to identify the potentially responsible factors.

The aim of this study was the rubustness evaluation of the chromatographic determination of nifedipine in medicines using Youden’s test.

Materials and methods. Youden’s test is a reliable method to evaluate the robustness of analytical methods, by means of an experiment design which involves seven analytical parameters combined in eight tests. In the present study, we assessed the robustness of a chromatographic method to quantify nifedipine using Youden’s test. Youden’s test showed to be a simple and feasible procedure to evaluate the robustness of chromatographic methods.

Results and discussion. Using the criteria of Youden’s test, the chromatographic method showed to be highly robust regarding of nifedipine content, when variations in seven analytical parameters were introduced. The highest variation in nifedipine content was 0.28 %, when the concen­tration of trifluoroacetic acid in the mobile phase was altered; a value considerably low and not significant in routine analyses.

Conclusions. Youden’s test showed to be a reliable and useful tool for the robustness evaluation of the chromatographic method for assay of nifedipine. Therefore, Youden’s test can be successfully applied for the ro­bustness evaluation in validation process of analytical methods by HPLC.


Keywords


nifedipine; validation; robustness; chromatography; quantitative analysis; Youden’s test

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References


ICH Topic Q2 (R1). (2005). Validation of Analytical Procedures: Text and methodology.

Da Costa Cesar, I., Pianetti, G. A. (2009). Robustness evaluation of the chromatographic method for the quantitation of lumefantrine using Youden’s test. Brazillian Journal of Pharmaceutical Sciences, 45, 235–240.

Karageorgou, E., Samanidou, V. (2014). Youden test application in robustness assays during method validation. Journal of Chromatography A, 1353, 131–139. doi: 10.1016/j.chroma.2014.01.050

Logoyda, L. (2015). Development and validation of new methods of analysis for the determination of different natural and synthetic original active pharmaceutical ingredients in medicines. Duphat, 48.

Logoyda L. (2017). The chromatographic determination of API from group of calcium channel blockers in medicines. Duphat, 67–68.

Logoyda L. (2017). Development of the methodology of the chromatographic determination of nifedipine in medicines. Asian Journal of Pharmaceutical and Clinical Research, 10 (3), 149–152.

Logoyda L. (2016). Validation of chromatographic methods of analysis for the determination of active pharmaceutical ingredients in different medicines. PharmaSchool association for pharmaceutical development and scientific research.Egypt, 34.


GOST Style Citations


1.         ICH Topic Q2 (R1) // Validation of Analytical Procedures : Text and methodology. – 2005.

2.         Da Costa Cesar, I. Robustness evaluation of the chromatographic method for the quantitation of lumefantrine using Youden’s test / I. da Costa Cesar, G. A. Pianetti // Brazillian J. of Pharmac. Sci. – 2009. – Vol. 45, Issue 2. – P. 235–240. doi: 10.1590/s1984–82502009000200007

3.         Karageorgou, E. Youden test application in robustness assays during method validation / E. Karageorgou, V. Samanidou // J. of Chromatography A. – 2014. – Vol. 1353. – P. 131–139. doi: 10.1016/j.chroma.2014.01.050

4.         Logoyda, L. Development and validation of new methods of analysis for the determination of different natural and synthetic original active pharmaceutical ingredients in medicines / L. Logoyda // Duphat. – 2015. – P. 48.

5.         Logoyda, L. The chromatographic determination of API from group of calcium channel blockers in medicines / L. Logoyda // Duphat. – 2017. – P. 67–68.

6.         Development of the methodology of the chromatographic determination of nifedipine in medicines / L. Logoyda, D. Korobko, I. Ivanusa, S. Kovalenko // Asian J. of Pharmac. and Clin. Res. – 2017. – Vol. 10, Issue 3. – P. 149–152.

7.         Logoyda, L. Validation of chromatographic methods of analysis for the determination of active pharmaceutical ingredients in different medicines / L. Logoyda // PharmaSchool association for pharmaceutical development and scientific research. –Egypt. – 2016. – P. 34.





DOI: https://doi.org/10.24959/ubphj.17.116

Abbreviated key title: Ukr. bìofarm. ž.

ISSN 2519-8750 (Online), ISSN 2311-715X (Print)