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Abstract

NEW ANALYTICAL METHOD DEVELOPMENT AND VALIDATION FOR ACEBROPHYLLINE (BRONCHODILATOR) DRUG

Ganesh Ghimire*, Akkamma H. G, Dr. C. Sreedhar, T. Sreenivasa Rao

ABSTRACT

A simple, economic, precise, and accurate reverse phase high performance liquid chromatographical method has been developed for the simultaneous estimation of acebrophylline in tablet dosage form. An enable x-bridgeTM, C18, 4.6×250mm, 5μm particle size column was used as stationary phase. The mobile phase consisting of a mixture of buffer (ammonium acetate PH 4.7) solution and acetonitrile (70:30) was pumped isocraticcally at a flow rate of 1ml/min with detection of 273nm. The retention time of acebrophylline were found to be 2.260 min. The calibration curves were linear over a concentration range of 10-60 μg/ml. with coefficient regration (r2) =0.9945 for acebrophylline. The limit of detection and limit of quantification were 0.329μg/ml 1.0975 μg/ml respectively for acebrophylline. The selectivity, specificity, system suitability, ruggedness and robustness were performed as per ICH guidelines. The percentage RSD was found to be less than 2. Due to simplicity, rapidity, and accuracy of the method with believe that the method will be useful for routine quality control analysis of acebrophylline in pharmaceutical dosage form.

Keywords: Acebrophylline, Accuracy, LOD, LOQ, RP-HPLC and validation.


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