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Validated RP- HPLC Method for the Quantitation of Ritonavir in Bulk and Capsule Dosage forms


Affiliations
1 Department of Pharmaceutical Analysis, Bharathi College of Pharmacy, Bharathi Nagara, K.M. Doddi, Maddur Taluk, Mandya District, Karnataka, India
     

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A simple, specific, accurate, precise and sensitive reverse phase high performance liquid chromatographic method has been developed for the quantitation of Ritonavir in both pure and capsule dosage forms. An intertsil C- 18, 5 μm column having 250×4.6 mm i.d. in isocratic mode with mobile phase containing acetonitrile: acetate buffer pH 4.0 (70:30). The flow rate was 1.0 ml/min and the effluents were monitored at 248 nm. The retention time was 3.12 min. The linearity was in the range of 10-50 mcg/ml. All the system suitability parameters were found within the range. This method was extensively validated for linearity, precision, specificity, limit of detection, limit of quantitation, accuracy, ruggedness and robustness. The recovery technique was performed to study the accuracy and reproducibility of the proposed method that the recovery of Ritonavir is satisfactory. Thus it can be concluded that the method in the present investigation is simple, sensitive, accurate, rapid and precise. The statistical analysis proves that the method is reproducible and selective. Hence, the above said method can be successfully applied for the routine estimation of Ritonavir in bulk and capsule dosage forms.

Keywords

Ritonavir, RP-HPLC, Validation
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  • Validated RP- HPLC Method for the Quantitation of Ritonavir in Bulk and Capsule Dosage forms

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Authors

C. Jose Gnana Babu
Department of Pharmaceutical Analysis, Bharathi College of Pharmacy, Bharathi Nagara, K.M. Doddi, Maddur Taluk, Mandya District, Karnataka, India
G. Vijaya Kumar
Department of Pharmaceutical Analysis, Bharathi College of Pharmacy, Bharathi Nagara, K.M. Doddi, Maddur Taluk, Mandya District, Karnataka, India

Abstract


A simple, specific, accurate, precise and sensitive reverse phase high performance liquid chromatographic method has been developed for the quantitation of Ritonavir in both pure and capsule dosage forms. An intertsil C- 18, 5 μm column having 250×4.6 mm i.d. in isocratic mode with mobile phase containing acetonitrile: acetate buffer pH 4.0 (70:30). The flow rate was 1.0 ml/min and the effluents were monitored at 248 nm. The retention time was 3.12 min. The linearity was in the range of 10-50 mcg/ml. All the system suitability parameters were found within the range. This method was extensively validated for linearity, precision, specificity, limit of detection, limit of quantitation, accuracy, ruggedness and robustness. The recovery technique was performed to study the accuracy and reproducibility of the proposed method that the recovery of Ritonavir is satisfactory. Thus it can be concluded that the method in the present investigation is simple, sensitive, accurate, rapid and precise. The statistical analysis proves that the method is reproducible and selective. Hence, the above said method can be successfully applied for the routine estimation of Ritonavir in bulk and capsule dosage forms.

Keywords


Ritonavir, RP-HPLC, Validation

References