Abstract
A novel stability-indicating LC assay method was developed and validated for quantitative determination of olmesartan in bulk drugs and in pharmaceutical dosage form in the presence of degradation products generated from forced degradation studies. An isocratic, reversed phase LC method was developed to separate the drug from the degradation products, using an Ace5-C18 (250 mm × 4.6 mm, 5 μm) column, and 50 mM ammonium acetate (pH-5.5 by acetic acid) and acetonitrile (70:30 v/v) as a mobile phase. The detection was carried out at the wavelength of 235 nm. The olmesartan was subjected to stress conditions of hydrolysis (acid, base), oxidation, photolysis and thermal degradation. Degradation was observed for olmesartan in acid, base and in 30% H2O2 conditions. The drug was found to be stable in the other stress conditions attempted. The degradation products were well resolved from the main peak. The percentage recovery of olmesartan ranged from (99.89 to 100.95%) in pharmaceutical dosage form. The developed method was validated with respect to linearity, accuracy (recovery), precision, specificity and robustness. The forced degradation studies prove the stability-indicating power of the method.
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References
Merck Index Merck & Co, Inc, USA, 13th edn (2001)
Chrysant SG, Chrysant GS (2004) Expert Opin Pharmacother 37:657. doi:10.1517/14656566.5.3.657
Chrysant SG, Weber MA, Wang AC, Hinman DJ (2004) Am J Hypertens 17:252. doi:10.1016/j.amjhyper.2003.11.003
Zhang XL, Yang HN (2006) China Pharma. Indust. Magazin. 10
Yang Y, Jianfang HN, Wang L (2006) China Pharma. Indust. Magazine. 20
Sagirli O, Onal A, Toker SE, Sensoy D (2007) Chromatographia 66:213–218. doi:10.1365/s10337-007-0304-9
Murakami T, Konno H, Fukutsu N, Onodera M, Kawasaki T, Kusu F (2008) J Pharm Biomed Anal 47:553–559. doi:10.1016/j.jpba.2008.02.021
Bakshi M, Singh B, Singh A, Singh S (2001) J Pharm Biomed Anal 26:1011–1040. doi:10.1016/S0731-7085(01)00475-7
Stability Testing of New Drug Substances and Products (Q1AR2), ICH Harmonised Tripartite Guideline
Validation of Analytical Procedures: Methodology (Q2B), ICH Harmonized Tripartite Guidelines
ICH, Text on validation of analytical procedures. Q2A
Singh S, Bakshi M (2000) Pharm Tecnol 26:24–31
Acknowledgments
The authors are grateful to Lupin Ltd. (Mumbai, India) for gift samples (olmesartan) and to the Head-Department of Chemical Technology, Dr. Babasaheb Ambedkar Marathawada University, Aurangabad, India for providing laboratory facilities for this research work.
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Rane, V.P., Patil, K.R., Sangshetti, J.N. et al. Stability-Indicating LC Method for the Determination of Olmesartan in Bulk Drug and in Pharmaceutical Dosage Form. Chroma 69, 169–173 (2009). https://doi.org/10.1365/s10337-008-0849-2
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DOI: https://doi.org/10.1365/s10337-008-0849-2