DEVELOPMENT AND VALIDATION OF STABILITY INDICATING RP-HPLC METHODFOR SIMULTANEOUS ESTIMATION OF ATORVASTATIN AND OLMESARTAN IN PHARMACEUTICAL DOSAGE FORM
Journal Title: Int J of Preclin & Pharm Res - Year 2014, Vol 4, Issue 6
Abstract
ABSTRACT A simple, precise, rapid, specific and accurate stability indicating reverse phase high performance liquid chromatography method was developed for simultaneous estimation of Atorvastatin (ATV) and Olmesartan (OLM) in pharmaceutical dosage form. Chromatographic separation was performed onAgilent eclipse XDB C8 (150x4.6mm, 5μ)column, with mobile phase comprising of mixture of buffer (pH3.25, adjusted with ortho phosphoric acid), and methanol in the ratio of 60:40v/v, at the flow rate 0.8 ml/min. The detection was carried out at 287 nm. The retention times of OLM and ATV were found to be 2.47 and 3.77 mins respectively with a run time of 6 mins, theoretical levels for OLM and ATV were 6248 and 4867 respectively, with a resolution of 7.57. As per ICH guidelines the method was validated for linearity, accuracy, precision, limit of detection and limit of quantitation, robustness and ruggedness. Linearity of OLM was found in the range of 120-360 μg/mL and that for ATV was found to be 60-180 μg/mL. The correlation coefficient for OLM and ATV were 1.000 and 0.999 respectively. The LOD values for OLM and ATV were 2.845 and 2.927 μg/mL respectively. The LOQ values for OLM and ATV were and 9.486 and 9.756 μg/mL respectively. This demonstrates that the developed method is simple, precise, rapid, selective, accurate and reproducible for simultaneous estimation of OLM and ATV tablet dosage form. Keywords: Atorvastatin (ATV), Olmesartan(OLM), RP-HPLC, Validation, Forced Degradation Studies.
Authors and Affiliations
Ranjeet Kumar V*, Sai Malakondaiah D, Ajitha A, Uma Maheshwara Rao V
Keywords
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