Main Article Content
Kanwar Manisha
Department of Pharmaceutical Chemistry, Maharshi Arvind College of Pharmacy, Ambabari, Jaipur-302039, Rajasthan, India
Goyal Pramod Kumar
Department of Pharmaceutical Chemistry, Maharshi Arvind College of Pharmacy, Ambabari, Jaipur-302039, Rajasthan, India
Sharma Piush
Department of Pharmaceutical Chemistry, Maharshi Arvind College of Pharmacy, Ambabari, Jaipur-302039, Rajasthan, India
Abstract
A new RP-HPLC method was developed for the estimation of bilastine tablet and it was validated as per ICH guidelines. The chromatogram for was found to be satisfactory on symmetry Aligent C-18 (250x4.6mm) 5µ column using Buffer: (Dipotassium hydrogen phosphate): Acetonitrile (pH adjusted at 7.0 using Orthophosphoric acid) in the ratio of 50:50 v/v at a flow rate of 1ml/min at 215nm. The peak of within limits was found well separated at 2.7 min. The retention time of bilastine were found to be 2.70 min. The system suitability parameters proved that the proposed method is suitable for estimation of bilastine. The method was found to be linear in the range of 5-20 μg/ml shows a correlation coefficient of 0.999 for a peak. The precision of the method was good and the recovery of drugs is well within the acceptance limits of 80-120%. The LOD was found to be 0.40 μg/ml and LOQ was found to be 1.42 μg/ml for bilastine. The developed method was validated for various parameters as per ICH guidelines like system suitability, specificity, linearity, system precision, method precision, accuracy, ruggedness and robustness.
Keywords: Bilastine, RP-HPLC, validation, estimation.