Stability-indicating UPLC method for determination of Valsartan and their degradation products in active pharmaceutical ingredient and pharmaceutical dosage forms

Journal of Pharmaceutical and Biomedical Analysis
Ch KrishnaiahK Mukkanti

Abstract

A simple, precise, accurate stability-indicating gradient reverse phase ultra-performance liquid chromatographic (RP-UPLC) method was developed for the quantitative determination of purity of Valsartan drug substance and drug products in bulk samples and pharmaceutical dosage forms in the presence of its impurities and degradation products. The method was developed using Waters Aquity BEH C18 (100 mm x 2.1 mm, 1.7 microm) column with mobile phase containing a gradient mixture of solvents A and B. The eluted compounds were monitored at 225 nm, the run time was within 9.5 min, which Valsartan and its seven impurities were well separated. Valsartan was subjected to the stress conditions of oxidative, acid, base, hydrolytic, thermal and photolytic degradation. Valsartan was found to degrade significantly in acid and oxidative stress conditions and stable in base, hydrolytic and photolytic degradation conditions. The degradation products were well resolved from main peak and its impurities, proving the stability-indicating power of the method. The developed method was validated as per international conference on harmonization (ICH) guidelines with respect to specificity, linearity, limit of detection, limit of quantification, accura...Continue Reading

References

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Citations

Aug 7, 2012·Archives of Pharmacal Research·Thao Truong-Dinh TranBeom-Jin Lee
Aug 24, 2013·Journal of Pharmaceutical and Biomedical Analysis·Deepti Jain, Pawan Kumar Basniwal
Nov 26, 2013·Chromatographia·Judyta Cielecka-PiontekPiotr Garbacki
Nov 15, 2013·Journal of Pharmaceutical Sciences·Izabela MuszalskaAnna Jelińska
May 20, 2011·Journal of Pharmaceutical and Biomedical Analysis·Romina M BianchiniTeodoro S Kaufman
May 6, 2014·Journal of Chromatographic Science·Venkata Vivekanand VallapragadaSreeramulu Jadi
Jan 10, 2021·Journal of Chromatographic Science·Xueyun Liu, Tianjiao Hu

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