Validation of the method of spectrophotometric determination of nicotinic acid in preparations

Keywords: method, linearity, precision, internal laboratory precision, specificity

Abstract

The optimum volume and concentration of hydrochloric acid is determined to prepare the solution of nicotinic acid. The main metrological characteristics of the spectrophotometric method are studied, namely, linearity, accuracy, precision, internal laboratory precision, specificity, and it is shown that this method can be used for the quantitative determination of nicotinic acid in Injectables "Nicotinic acid - Health" with ± 5% tolerance of active ingredient content. The method ensures reproducible results.

Downloads

Download data is not yet available.

References

Derjavna Farmakopeya Ukrai`ni - 1-e vid. - Derjavne pi'dprie''mstvo «Naukovo-ekspertniy farmakopeyniy centr».- Harki'v: RI'REG. 2001. - 556 s.

Li'kars'ki' zasobi. Nalejna virobnicha praktika: ST-N MOZU 42-4.0:2011. - [CHinniy vi'd 2011-06-07] - K.: Mi'ni'sterstvo ohoroni zdorov'ya Ukrai`ni, 2011. - 268 s.

Directive 2004/9/ES of the European Parliament and of the Council of 11 February 2004 on the inspection and verification of good laboratory practice (GLP) / Official Journal of the European Union. - 2004. - Vol. 50. - P. 28-43.

Directive 2004/10/EC of the European Parliament and of the Council of 11 February 2004 on the inspection and verification of good laboratory practice (GLP) / Official Journal of the European Union. - 2004. - Vol. 50. - P. 44-59

Standartizovannaya procedura validacii metodik kolichestvennogo analiza lekarstvenny'h sredstv metodom standarta / A.I. Grizodub, D.A. Leont'ev, N.V. Denisenko, YU.V. Podpru-jnikov // Farmakom. - 2004. - №3. - S. 3-16.

Derjavna Farmakopeya Ukrai`ni - 1-e vid. Dopovnennya 2.- Derjavne pi'dprie''mstvo «Nau-kovo-ekspertniy farmakopeyniy centr».- Harki'v: RI'REG.- 2008. - 620 s.

Brown R., Analytical Procedures and Method Validation: Highlights of the FDA's Draft Guid-ance / R. Brown, M. Caphart, P. Faustino et al. // LCGC. - 2001. - Vol. 19, №. l.- P. 74-79.

Hiremath B. Development and validation of spectrophotometric methods for determination of ceftazidime in pharmaceutical dosage forms / B. Hiremath, B.H.M. Mruthyunjayaswamy // Acta Pharm.– 2008. – № 58. – P. 275-285

Hryzodub A.Y. Vosproyzvodymost' farmakopeynыkh spektrofotometrycheskykh metodyk kolychestvennoho opredelenyya lekarstvennыkh sredstv v raznыkh laboratoryyakh / A.Y. Hryzodub, N. N. Zvolynskaya, D.A. Leont'ev y dr. // Farmakom. – 2004. – #2. – C. 1-16.

Published
2014-10-28
Cited
How to Cite
Yurchenko, O. I., Osipov, A. V., Dobriyan, M. A., & Chernozhuk, T. V. (2014). Validation of the method of spectrophotometric determination of nicotinic acid in preparations. Kharkiv University Bulletin. Chemical Series, (24), 140-144. https://doi.org/10.26565/2220-637X-2014-24-17