Open Access Open Access  Restricted Access Subscription Access
Open Access Open Access Open Access  Restricted Access Restricted Access Subscription Access

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
     

   Subscribe/Renew Journal


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
Subscription Login to verify subscription
User
Notifications
Font Size


  • Lippincott Williams and Wilkins Remington The science and practice of pharmacy 21st ed. Wolter Kluwer Health (India) Pvt. Limited New Delhi 2005 Vol II: 1679-1683.
  • Carolina Lupi Dias, Ana Maria Bergold and pedro Forlich. UVDerivative Spectrophotometric Determination of Ritonavir Capsules and comparison with LC method. Anal letters. 42(12); 2009: 1900-1910.
  • Vaishali and Kishore. Simultaneous estimation of Ritonavir and Lopinavir by absorbance ratio UV Spectrophotometric method in combined tablet dosage form. Des Pharmacia Lettre. 2(1); 2010: 196-200.
  • Chiranjeevi, Channabasavaraj and Srinivas Reddy. Development and validation of spectrophotometric method for the determination of Ritonavir in bulk and pharmaceutical dosage forms. International journal chemtech research. 3; 2011: 58-62.
  • Channabasavaraj KP and Chiranjeevi K. Development and validation of RP-HPLC method for quantitative estimation of Ritonavir in bulk and pharmaceutical dosage form. International journal of pharmaceutical sciences and research. 2; 2011: 596- 600.
  • Suneetha A, Kathirvel S and Ramachandrika G A. Validated RPHPLC method for simultaneous estimation of Lopinavir and Ritonavir in combined dosage form. International journal of pharmacy and pharmaceutical sciences. 2; 2011: 49-51.
  • Veera venkata Satyanarayana Peruri and Murali musuluri. A validated RP-HPLC method for the estimation of Ritonavir in pharmaceutical dosage forms. Journal of pharmacy research. 4; 2011: 3049-3051.
  • Sudha T Vanitha R and Ganesan V. Development and validation of RP-HPLC and HPTLC methods for the estimation of Ritonavir in bulk and pharmaceutical formulation. Der pharma chemical. 3; 2011: 127-134.
  • Robert A Nash and Alfred H Wachter. Pharmaceutical Process Validation. An international 3rd edition. New York. James Swarbrick, North Carolina, Revised and Expanded, Volume 129, Marcel Dekker,Inc., 507-522.
  • International Conference on Harmonization of Technical Requirements for the Registration of Pharmaceuticals for Human use. Validation of Analytical procedures: Methodology. ICHQ2B, Geneva(1996);(CPMP/ICH/281/95), Internet: http://www.nihs.go.jp/ drug/validation/q2bwww.html.
  • Green JM. A practical guide to analytical method validation, anal chem. News Feat 305A/309A (May 1, 1996).

Abstract Views: 307

PDF Views: 1




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

Abstract Views: 307  |  PDF Views: 1

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