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A Validated and Simplified RP-HPLC of Metoprolol Succinate from Bulk Drugs


Affiliations
1 Department of Pharmaceutical Analysis, Prin. K. M. Kundnani College of Pharmacy, 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 (RP-HPLC) was developed and validated for the estimation of Metoprolol succinate from bulk drugs. A RP Spherisorb C-18 (Waters) 10μm column having 250×4.6 mm ID in isocratic mode, with mobile phase containing acetonitrile: methanol: 10 mM aqueous phosphate buffer (20:20:60%v/v) was used. The flow rate was 1.0 ml/min and effluents were monitored at 254 nm. The retention time of Metoprolol succinate was 5.1 min. The linearity of the method was good (r > 0.998), as also were intra-day and inter-day precision (RSD <2%).

The method was validated for accuracy, specificity, limit of quantification, limit of detection, robustness and stability. The results showed that proposed method is successfully applied for the quantitative determination of Metoprolol succinate in bulk drugs.


Keywords

Reverse Phase Liquid Chromatography, Metoprolol Succinate, HPLC, Specificity, Validation.
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  • A Validated and Simplified RP-HPLC of Metoprolol Succinate from Bulk Drugs

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Authors

Mitesh D. Phale
Department of Pharmaceutical Analysis, Prin. K. M. Kundnani College of Pharmacy, Jote Joy Building, Rambhau Salgaonkar Marg, Cuffe Parade, Colaba, Mumbai- 400 005, India
Purnima D. Hamrapurkar
Department of Pharmaceutical Analysis, Prin. K. M. Kundnani College of Pharmacy, 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 (RP-HPLC) was developed and validated for the estimation of Metoprolol succinate from bulk drugs. A RP Spherisorb C-18 (Waters) 10μm column having 250×4.6 mm ID in isocratic mode, with mobile phase containing acetonitrile: methanol: 10 mM aqueous phosphate buffer (20:20:60%v/v) was used. The flow rate was 1.0 ml/min and effluents were monitored at 254 nm. The retention time of Metoprolol succinate was 5.1 min. The linearity of the method was good (r > 0.998), as also were intra-day and inter-day precision (RSD <2%).

The method was validated for accuracy, specificity, limit of quantification, limit of detection, robustness and stability. The results showed that proposed method is successfully applied for the quantitative determination of Metoprolol succinate in bulk drugs.


Keywords


Reverse Phase Liquid Chromatography, Metoprolol Succinate, HPLC, Specificity, Validation.