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A Validated and Simplified RP-HPLC Method for Estimation of Ebastine from Bulk Drugs


Affiliations
1 Department of Pharmaceutical Analysis, Prin. K. M Kundnani College of Pharmacy, Plot no: 23, Jote Joy Building, Rambhau Salgaonkar Marg, Cuffe Parade, Colaba, Mumbai- 400 005, India
     

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A simple, specific, accurate and precise reverse phase liquid chromatographic method was developed and validated for the estimation of Ebastine from Bulk drugs. A RP HiQ Sil C8 HS column having 250x4.6 mm ID and 5 μm particle size in isocratic mode, with mobile phase containing Methanol and 10 mM Ammonium dihyrogen orthophosphate (80:20 % v/v) was used at the flow rate of 1.0 ml/min. The effluents were monitored at 255 nm. The retention time of Ebastine was 5.9 min. The linearity of the method was good (r > 0998), as also were intra-day and inter-day precision (RSD) < 2 %). The method is validated for accuracy, specificity, limit of quantification, limit of detection, robustness and stability. The results show that proposed method can be successfully applied for the quantitative determination of Ebastine.


Keywords

Reverse Phase Liquid Chromatography, Ebastine, HPLC, Specificity, Validation, Linearity, Robustness, Methanol and 10 mM Ammonium Dihyrogen Orthophosphate.
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  • A Validated and Simplified RP-HPLC Method for Estimation of Ebastine from Bulk Drugs

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Authors

P. N. Agrawal
Department of Pharmaceutical Analysis, Prin. K. M Kundnani College of Pharmacy, Plot no: 23, Jote Joy Building, Rambhau Salgaonkar Marg, Cuffe Parade, Colaba, Mumbai- 400 005, India
Namrata E. Teli
Department of Pharmaceutical Analysis, Prin. K. M Kundnani College of Pharmacy, Plot no: 23, Jote Joy Building, Rambhau Salgaonkar Marg, Cuffe Parade, Colaba, Mumbai- 400 005, India

Abstract


A simple, specific, accurate and precise reverse phase liquid chromatographic method was developed and validated for the estimation of Ebastine from Bulk drugs. A RP HiQ Sil C8 HS column having 250x4.6 mm ID and 5 μm particle size in isocratic mode, with mobile phase containing Methanol and 10 mM Ammonium dihyrogen orthophosphate (80:20 % v/v) was used at the flow rate of 1.0 ml/min. The effluents were monitored at 255 nm. The retention time of Ebastine was 5.9 min. The linearity of the method was good (r > 0998), as also were intra-day and inter-day precision (RSD) < 2 %). The method is validated for accuracy, specificity, limit of quantification, limit of detection, robustness and stability. The results show that proposed method can be successfully applied for the quantitative determination of Ebastine.


Keywords


Reverse Phase Liquid Chromatography, Ebastine, HPLC, Specificity, Validation, Linearity, Robustness, Methanol and 10 mM Ammonium Dihyrogen Orthophosphate.