Stability Indicating RP-HPLC Method for Azilsartan Related Substances in Solid Dosage Forms

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International Journal of Research and Scientific Innovation (IJRSI) | Volume IV, Issue XII, December 2017 | ISSN 2321–2705

Stability Indicating RP-HPLC Method for Azilsartan Related Substances in Solid Dosage Forms

O. S. S. Chandana[1], R. Ravichandrababu[2]
[1] Aditya College of Engineering, Surampalem, Andhra Pradesh, India
[2] Department of Chemistry, Institute of Science, GITAM University, Visakhapatnam, Andhra Pradesh, India


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Objective: The main objective of the research work was to develop a simple, accurate, stability indicating RP-HPLC method for the quantification of Azilsartan and its related substances.

Method: The method was developed by Hitachi Lachrome HPLC with the Develosil ODS HG-5 RP C18, (5µm,15 cm x4.6mm) , it has a mobile phase of buffer, methanol and acetonitrile(ACN) in the ratio of 60:30:10v/v/v was used. The flow rate was set at 1.0 ml/ min. ml/min with a detection wavelength of 243nm using VWD detector. The method was validated for analytical parameters such as specificity, accuracy, precision, robustness and ruggedness as per ICH guidelines.

Results: Under the specificity experiment, samples were stressed under various stress conditions and analyzed along with unstressed samples. AZM was found to be very stable under all degradation conditions. The developed method can be used for routine analysis because the linearity found in AZM, Impurity A, Impurity B, Impurity C and Impurity D was nearing 1 that is 0.999, 0.998, 0.997, 0.999 and 0.998 respectively which shows the good regression for linearity. The results from solution stability experiments confirmed that standard and sample solutions were stable up to 24 h for both assay and related substances analysis. Maximum recovery is obtained by this developed method and the mean percentage recovery for each component was nearing 100%.

Conclusion: Statistical validation of the data shows that the proposed method can be successfully applied for the routine analysis of the AZM and related substances. The satisfying % recoveries and low % RSD values were confirmed the suitability of the developed method for the usual analysis of AZM and related substances in pharmaceuticals.

Keywords: Azilsartan, HPLC, Stability indicating, method development, validation


Azilsartan medoxomil (AZM) is chemically known as 5- methyl-2-oxo-1,3-dioxol-4-yl)methyl2-ethoxy-1-([2′-(5- oxo-4,5-dihydro-1,2,4-oxadiazol-3-yl)biphenyl-4-yl]methyl)- 1Hbenzimidazole-7-carboxylate. The chemical formula ofAzilsartan medoxomil is C25H20N4O5with molecular weight of 456.46 g/Mol. Azilsartan medoxomil is white powder which is practically insoluble in water and freely soluble in methanol The development and validation of an analytical method is to ensure a specific, accurate and precise method for a particular analyte.