Stability Indicating RP-HPLC Method for Bosentan in Tablet Dosage form

R. M. Gaurkhede, A. V. Chandewar

Abstract


A simple, precise and reproducible stability indicating HPLC method has been developed and validated for determination Bosentan on an Intersil ODS column (250*4.6*5um) using a mobile phase consisting of Disodium phosphate Buffer and acetonitrile (30:70) at flow 1.0 ml/min. Detection was carried out at 273nm . The method was validated with respect to specificity, accuracy linearity, precession, ruggedness and robustness parameters as per ICH guidelines. Linearity of the method was found to be 0.999; %RSD of precession was below 2.0%, recovery of added drug within 98-102 %, System suitability parameters were within limit for Bosentan. The Degradation study was performed during different stress conditions in stability studies. The results obtained in this research work are indicated that the developed method is simple, accurate and precise, sensitive and applicable for analysis in commercially available formulation sample.

Keywords


Validation, ICH, RP-HPLC, Stress degradation study

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References


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DOI: http://dx.doi.org/10.7439/ijbar.v8i10.4456

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