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A NOVEL VALIDATED STABILITY INDACATING METHOD OF OLMESARTAN BY USING REVERSE PHASE CHROMATOGRAPHIC TECHNIQUES

Journal Name:

  • The International Journal of Pharmaceutical Research and Bio-Science

Publication Year:

  • 2013

Key Words:

Author NameUniversity of Author
Abstract (2. Language): 
The objective of the current study was to develop and validate a rapid, precise, specific and stability-indicating reverse phase HPLC method for the quantitative determination of olmesartan in its dosage form. The determination is done for the active pharmaceutical ingredient in its pharmaceutical dosage form in the presence of degradation products. The drug was subjected to stress conditions of acid, alkali, thermal, photolytic, humidity and peroxide. As per international conference on harmonization (ICH) prescribed stress conditions to show the stability-indicating power of the method. It was found olmesartan is very sensitive to various stress conditions. The chromatographic conditions were optimized using the samples generated from forced degradation studies. Regression analysis shows an r value (correlation coefficient) 0.999 for olmesartan. The chromatographic separation was achieved on a symmetry C18 stationary phase. The method employed an isocratic elution and the detection wave-length was set at 379 nm. The mobile phases consists of water and methanol delivered at a flow rate of 1.5 mL/min. The developed RP-HPLC method was validated with respect to linearity, accuracy, precision and robustness.
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