AJAC  Vol.3 No.2 , February 2012
Development and Validation of Stability Indicating LC Method for Olmesartan Medoxomil
Abstract: The present method provides the detailed description of development and validation of a simple stability indicating re- verse phase column liquid chromatographic method for Olmesartan in the presence of its impurities namely Imp-A, Imp-B, Imp-C, Imp-D, Imp-E, Imp-F and Imp-G and degradation products generated from forced degradation studies. The drug substance was subjected to stress conditions of aqueous hydrolysis, Oxidative, photolytic and thermal stress degradation. The degradation of Olmesartan was observed under acid hydrolysis, base hydrolysis and peroxide. The drug was found to be stable to other stress conditions attempted. Successful separation of the drug from synthetic impu- rities and degradation products formed under stress conditions was achieved on symmetry C18, 150 mm × 4.6 mm, 5μ column using a phosphate buffer, Acetonitrile and Milli Q water. The developed LC method was validated with respect to specificity, linearity, accuracy, precision, raggedness and robustness. The assay method was found to be linear in the range of 250 μg?mL–1 to with 1000 μg?mL–1 correlation coefficient of 0.9999 and the linearity of the impurities was es- tablished from LOQ to 0.4%. Recoveries of assay and impurities were found between 98.5% and 101.2%. The devel- oped LC method to determine the related substances and assay determinations of Olmesartan can be used to evaluate the quality of regular production samples and stability samples. To best of our knowledge, the validated stability indi- cating LC method which separates all the impurities disclosed in this investigation was not published elsewhere.
Cite this paper: C. Rao, K. Kumar, M. VijayaLaxmi, P. Srinivasulu, G. Madhusudhan, K. Mukkanti and K. Srinivas, "Development and Validation of Stability Indicating LC Method for Olmesartan Medoxomil," American Journal of Analytical Chemistry, Vol. 3 No. 2, 2012, pp. 153-160. doi: 10.4236/ajac.2012.32022.

[1]   K. koga, S. Yamagishi, M. Takeuchi, Y. Inagaki, S. Amano, T. Okamoto, T. Saga, Z. Makita and M. Yoshizuka, “Serum Levels of Glucose-Derived Advanced Glycation End Products Are Associated with the Severity of Diabetic Retinopathy in Type 2 Diabetic Patients without Renal Dysfunction,” International Journal of Clinical Pharmacology Research, Vol. 22, No. 1, 2002, pp. 7-13.

[2]   L. R. Schwocho and H. N. Masonson, “Pharmacokinetics of CS-866, a New Angiotensin I Receptor Blocker, in Healthy Subjects,” Journal of Clinical Pharmacology, Vol. 41, No. 5, 2001, pp. 515-527. doi:10.1177/00912700122010393

[3]   B. S. Lee, M. J. Kang, W. S. Choi, Y. B. Choi, H. S. Kim, S. K. Lee and Y. W. Choi, “Solubilized Formulation of Olmesartan Medoxomil for En-hancing Oral Bioavailability,” Archives of Pharmacal Research, Vol. 32, No. 11, 2009, pp. 1629-1635. doi:10.1007/s12272-009-2117-x

[4]   O. Sagirli, A. Onal, S. E. Toker and D. ?ensoy, “Simultaneous HPLC Analysis of Olme-sartan and Hydrochlorothiazide in Combined Tablets and in vitro Dissolution Studies,” Chromatographia, Vol. 66, No. 3-4, 2007, pp. 213-218. doi:10.1365/s10337-007-0304-9

[5]   International Conference on Harmonization (ICH Guide- Lines, Q3A(R) Impurities in New Drug Substances, October 2006.

[6]   R. B. Gandurib, R. A. Lankaa, et al., “New RP-HPLC Method for The Determination of Olmesartan Medoxomil in Tablet Dosage Form,” Eurasian Journal of Analytical Chemistry, Vol. 5, No. 2, 2010, pp. 145-151.

[7]   A. R. Rote and P. D. Bari, “Spectrophotometric Estimation of Olmesartan Medoxomil and Hydrochlorothiazide in Tablet,” Indian Journal of Pharmaceutical Sciences, Vol. 72, No. 1, 2010, pp. 111-113. doi:10.4103/0250-474X.62245

[8]   Stability Testing of New Drug Substances and Drug Products Q1 A (R2), International Conference on Harmonization, IFPMA, Geneva, 2003.

[9]   USP 2011 United States of Pharmacopoeia, 34th Edition, “United States Pharmacopial Drug Stability Principles and Practices (2000),” In: J. T. Carstensen and C. T. Rhodes, Eds., 3rd Edition, Marcel Dekker, New York.

[10]   M. Bakshi and S. Singh, “Development of Validated Stability Indicating Assay Methods Critical Review,” Journal of Pharmaceutical and Biomedical Analysis, Vol. 28, No. 6, 2002, pp. 1011-1040. doi:10.1016/S0731-7085(02)00047-X

[11]   R. N. Sharma and S. S. Pnacholi, “RP-HPLC-DAD Method for Determination of Olmesartan Medoxomil in Bulk Drug and Tablets Exposed to Forced Conditions,” Acta Pharmaceutica, Vol. 61, No. 1, 2010, pp. 13-24. doi:10.2478/v10007-010-0010-2

[12]   P. Sengupta, A. Das and T. K. Pal, “Stability Indicating RP-HPLC Method for Simulta-neous Determination of Olmesartan Medoxamil and Pioglitazone in Fixed Dose Combination Tablet Dosage Form,” Vol. 22, No. 8, 2010, pp. 6471-6479.