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  • Analytical Method Development and Validation for Lopinavir and Ritonavir in Bulk and Dosage Form
  • Department of Pharmaceutical Quality Assurance, Rajarshi Shahu College of Pharmacy, Buldana 443001, Maharashtra, India.

Abstract

Objective: A simple, accurate and precise RP-HPLC method for simultaneous determination of Lopinavir and Ritonavir in bulk and dosage forms. Methods: A reversed phase high-performance liquid chromatographic (RP-HPLC) method was developed and validated for the quantitative determination of lopinavir (LPV) and ritonavir (RTV) on Agilent C18 (2) 250 × 4.6 mm, 5 ? column as a stationary phase and mobile phase composition of Acetonitrile: 0.1% Ortho-phosphoric acid (pH 3.5) (80:20, v/v) at a flow rate of 1ml/min. Results: Quantification was achieved with UV detection at 217 nm. The retention times of Lopinavir and Ritonavir was 7.38 and 2.98 min respectively. The result of linearity was obtained in the concentration range of 0-20µg/ml for both Ritonavir and Lopinavir. %Recovery was Obtained as 99.25% and 99.72% for Ritonavir and Lopinavir respectively. LOD, LOQ values are obtained from regression equations of Ritonavir and Lopinavir were 4.6ng/spot, 1.5ng/spot, 5.10ng/spot, 21.00ng/spot respectively. Regression equation of Ritonavir and Lopinavir Y= 0.1828x - 0.0236 and y = 0.1639x - 0.0261. Retention times are decreased and that run time was decreased so the method developed was simple and economical that can be adopted in regular Quality control test in Industries.

Keywords

ritonavir, lopinavir, acetonitrile, RP-HPLC, validation

Reference

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  2. Jadhav SR. Alhat HP. Joshi SV. Analytical methods development and validation for simultaneous estimation of Lopinavir and ritonavir in pharmaceutical formulation by simultaneous equation method using UV spectrophotometry. International Research Journal of Pharmacy, 2018; 9(8): 57-62.
  3. Devineni. Jyothirmayee. Vasumathi Rangani. Sravya Nunna. New sensitive UV Spectrophotometric method for simultaneous estimation of lopinavir and ritonavir in fixed dose combination as soft gels. International Journal of Pharmaceutical Development and technology, 2016; 7 (1): 25-30.
  4. Namratha Sunkara. A.Vijayalakshmi. UV Spectrophotometric method development and validation of lopinavir in bulk and pharmaceutical dosage form. Centre for Info BioTechnology Journal of Pharmaceutical Sciences, 2017;6 (2): 1-4.
  5. Peerzade. Mohammad Yasir. Shakeel Memon. Kiran Bhise. Ansari Irfan Aamer. Development and validation of UV Visible spectrophotometric method for estimation of ritonavir in bulk and formulation. Pharma Innovation journal, 2019; 8 (4): 30-34.
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  7. Geetha Bhavani K. Srinivasu N. Nanduri Gayatri Devi. D. Ramachandran. Development and validation of RP-LC method for ritonavir in pharmaceutical formulations. International Journal of Pharmaceutical Research, 2017; 7 (3): 115-125.
  8. Shivanand N. Hiremath and Charushila H. Bhirud, P. Development and validation of a stability indicating HPLC method for the simultaneous analysis of lopinavir and ritonavir in fixed-dose combination tablets. Journal of Taiba University of Medicinal Science, 2015; 10 (3): 271-277.
  9. Abdelhay, M.H, Gazy, A.A, Shaalan, R.A. and Ashour H.K. Validated stability indicating HPLC and HPTLC methods for the determination of ritonavir in bulk powder and in capsules. Journal of Food and Drug Analysis ,2012; 20 (4): 26-28.

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Archana B. Chavhan
Corresponding author

Department of Pharmaceutical Quality Assurance, Rajarshi Shahu College of Pharmacy, Buldana 443001, Maharashtra, India.

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Vijay S. Borkar
Co-author

Department of Pharmaceutical Quality Assurance, Rajarshi Shahu College of Pharmacy, Buldana 443001, Maharashtra, India.

Archana B. Chavhan*, Vijay S. Borkar, Analytical Method Development and Validation for Lopinavir and Ritonavir in Bulk and Dosage Form, Int. J. in Pharm. Sci., 2023, Vol 1, Issue 8, 111-117. https://doi.org/10.5281/zenodo.8247500

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