RP-HPLC Analytical Method Development and Validation for the Determination of Olmesartan Medoxomil in Bulk Drug and Tablets
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Keywords

Olmesartan medoxomil
reversed-phase
RP-HPLC
ICH validation
Analysis

Abstract

A simple, economic, accurate, sensitive and precise reverse phase high performance liquid chromatographic (RP-HPLC) method for the determination of Olmesartan Medoxomil in bulk drug and tablet dosage form was developed and validated as per the ICH Harmonised Tripartite Guideline. The chromatographic separation was carried out on Hypersil GOLD C18 column (150mm × 4.6mm, 5μm ) with acetonitrile and phosphate buffer pH 3 (35:65%) containing 1% of glacial acetic acid at a flow rate of 1.2mL/min and the PDA detection set at 255nm. A linear response was observed over the concentration from 5μg/mL to 25μg/mL (r2 = 0.9999). The recoveries were found to be between 99.47% - 100.35% and the corresponding RSDs between 0.52-0.68. The validation data proved that the assay undergone is sensitive, reproducible and economical and thus can be used for the routine estimation of Olmesartan medoxomil in bulk drug and tablets dosage form.
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References

Aulakh GK, Sodhi RK, Singh M. An update on non-peptide angiotensin receptor antagonists and related RAAS modulators. Life Sci. 2007;81(8):615-39. http://dx.doi.org/10.1016/j.lfs.2007.06.007

Brousil JA, Burke JM. Olmesartan medoxomil: an angiotensin II-receptor blocker. Clin Therap. 2003;25(4):1041-55. http://dx.doi.org/10.1016/S0149-2918(03)80066-8

Prasad CM, Vidyasagar G, Sambasiva Rao K, Ramanjeneyulu S. Development of RP-HPLC method for estimation of Olmesartan Medoxomil in tablet dosage forms. Der Pharma Chem. 2011;3(6).

Ganduri RB, Lanka RA, Pamidi S, Peddareddigari JR, Mohammed M. New RP-HPLC method for the determination of olmesartan medoxomil in tablet dosage form. Eurasian J Anal Chem. 2010;5(2):145-51.

Kardile DP, Kalyane NV, Thakkar TH, Patel MR, Moradiya RK. Simultaneous estimation of amlodipine besylate and olmesartan medoxomil drug formulations by HPLC and UV-spectrophotometric methods. J Pharm Sci Res. 2010;2(9):599-614.

Vaidya VV, Roy SMN, Yetal SM, Joshi SS, Parekh SA. LC–MS–MS determination of olmesartan in human plasma. Chromatogr. 2008;67(1-2):147-50. http://dx.doi.org/10.1365/s10337-007-0453-x

Chimalakonda Kameswara R, Kakumani Kishore K, Maddala V, Polisetty S, Gutta M, Khagga M, et al. Development and validation of stability indicating LC method for olmesartan medoxomil. Am J Anal Chem. 2012;2012. http://dx.doi.org/10.4236/ajac.2012.32022

Sharma R, Pancholi S. RP-HPLC-DAD method for determination of olmesartan medoxomil in bulk and tablets exposed to forced conditions. Acta Pharm. 2010;60(1):13-24. http://dx.doi.org/10.2478/v10007-010-0010-2

Muralidharan S, Rajkumar JR. Sensitive estimation of Olmesartan medoxomil tablets by RP-HPLC method. Int J Pharm Life Sci. 2012;3(11):2149-52.

Jain PS, Chaudhari AJ, Surana SJ. Development and validation of stability-indicating RP-HPLC method for determination of Olmesartan medoxomile in pharmaceutical dosage form and identification, characterization of alkaline degradation impurity of Olmesartan medoxomile drug substance as well as drug product. Chem Ind Chem Eng Q. 2012;18(4-1):595-604. http://dx.doi.org/10.2298/CICEQ111204035J

Hamrapurkar PD, Gadapayale KK. Optimization and Validation of RP-HPLC Stability Indicating method for determination of olmesartan medoxomil and Its degraded product. Int J Appl Sci Eng. 2013;11(2):137-47.

Trivedi P, Kartikeyan C, Kachave R, Bhadane R. Stability-indicating assay method for estimation of olmesartan medoxomil and its metabolite. J Liq Chromatogr Rel Tech. 2009;32(10):1516-26. http://dx.doi.org/10.1080/10826070902901606

Sagirli O, Önal A, Toker SE, Şensoy D. Simultaneous HPLC analysis of olmesartan and hydrochlorothiazide in combined tablets and in vitro dissolution studies. Chromatogr. 2007;66(3-4):213-8. http://dx.doi.org/10.1365/s10337-007-0304-9

Patil PS, More HN, Pishwikar SA. RP-HPLC method for simultaneous estimation of Amlodipine besylate and Olmesartan medoxomil from tablet. Int J Pharm Pharm Sci. 2011;3(suppl 3):3-6.

Rao JR, Rajput MP, Yadav SS, Mulla TS, Bharekar VV. Simultaneous quantitation of olmesartan medoxomil, Amlodipine besylate and hydrochlorothiazide in pharmaceutical dosage form by using HPLC. Int J PharmTech Res. 2011;3:1435-40.

Sidhdhapara Mital J, Patel B, Paramar A. Development and validation of RP-HPLC method for simultaneous estimation of Cilnidipine and Olmesartan medoxomil in their combined tablet dosage form. Int J Pharm Biosci. 2014;4(1):157-60.

Raja B, Rao AL. Development and validation of a reversed phase hplc method for simultaneous estimation of olmesartan and hydrochlorothiazide in combined tablet dosage form. Int J Res Pharm Chem. 2011;1(3):714-7.

Amudhavalli V, Lakshmi K, Karthick M. Determination of olmesartan and hydrochlorthiazide in pharmaceutical formulations by RP-HPLC. Int J Chem Sci. 2011;9(2):470-6.

Qutab SS, Razzaq SN, Ashfaq M, Khan IU, Mumtaz A. Simultaneous quantitation of olmesartan medoxomil and amlodipine besylate in combined tablets using HPLC. J Chil Chem Soc. 2009;54(3):234-7.

Mohan Rao T, Velrajan G, Sekhar KC. An Improved RP-HPLC Method for simultaneous estimation of Ramipril and Olmesartan in tablet dosage form. Am J Pharm Tech Res. 2013;3(3).

Patel MM, Patel DD. Simultaneous Estimation of Metoprolol Succinate and Olmesartan Medoxomil in Pharmaceutical Dosage Form by RP-HPLC. J Chromatogr Sep Tech. 2012;3(151):2. http://dx.doi.org/10.4172/2157-7064.1000151

Devanaboyina N, Satyanarayana T, Rao BG. Simultaneous determination of olmesartan and hydrochlorothiazide in combined pharmaceutical dosage form by Rp-Hplc method. Int J Pharm Biosci. 2012;3(2):107-15.

Kamble AY, Mahadik MV, Khatal LD, Dhaneshwar SR. Validated HPLC and HPTLC method for simultaneous quantitation of amlodipine besylate and olmesartan medoxomil in bulk drug and formulation. Anal Lett. 2010;43(2):251-8. http://dx.doi.org/10.1080/00032710903325906

Guideline ICHHT. Validation of analytical procedures: Text and Methodology Q2 (R1). 2005.

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