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Asian Journal of Pharmaceutical Research
Year : 2015, Volume : 5, Issue : 1
First page : ( 15) Last page : ( 23)
Print ISSN : 2231-5683. Online ISSN : 2231-5691.
Article DOI : 10.5958/2231-5691.2015.00003.9

Development and Validation of Stability Indicating high performance liquid chromatographic Method for Olmesartan medoxomil and Indapamide in Tablet

Patel Rucha A1,*, Patel Meghna P.1, Raj Hasumati A.1, Shah Nehal2

1Department of Quality Assurance, Shree Dhanvantry Pharmacy College, Kim, Surat, Gujarat, India

2Dharmaj Degree of Pharmacy, Dharmaj, Anand, Gujarat, India

*Corresponding Author E-mail: ruchajigar6114@gmail.com

Online published on 2 May, 2015.


An approach of forced degradation study was successfully applied for the development of a stability-indicating high performance liquid chromatographic method for simultaneous determination of Olmesartan medoxomil and Indapamide in a formulation in the presence of its degradation products. In the present study a simple, accurate and precise reverse phase liquid chromatographic method has been developed and validated for simultaneous estimation of Olmesartan medoxomil and Indapamide in tablet dosage form. Developed Method was achieved on symmetry C18 (150 mm × 4.6 mm, 5 μ) column using a Acetonitrile: 0.02 M Na2HPO4 (45:55 v/v) mobile phase and pH 7 adjusted with ortho phosphoric acid. Isocratic elution mode at a flow rate of 1.0 ml/min at Room temperature with a load of 20μl Injection volume. The detection was carried out at 240 nm. The linearity of the proposed method was investigated in the range of 50–250 microg/mL (r2 = 0.998) for Olmesartan medoxomil and 10–50 microg/mL (r2 = 0.998) for Indapamide. The retention time of Olmesartan medoxomil and Indapamide were found to be around 4.79 min and 7.59 min respectively. The drug substances were subjected to stress conditions of acid hydrolysis, base hydrolysis, Oxidative, photolytic and thermal. The developed RP-HPLC method was validated with respect to linearity, accuracy, precision, robustness, LOD and LOQ.



Olmesartan medoxomil, Indapamide, Hypertension, stability study.


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