Method Development and Validation for Multicomponent Analysis of Emtricitabine and Ritonavir in Bulk Drug by RP-HPLC

  • Aman Kapoor Department of Pharmaceutical Analysis and Quality Assurance, Laureate Institute of Pharmacy Kathog Jawalaji, India
  • Amar Deep Ankalgi Department of Pharmaceutical Analysis and Quality Assurance, Laureate Institute of Pharmacy Kathog Jawalaji, India
  • Upasana Thakur Department of Pharmaceutical Analysis and Quality Assurance, Laureate Institute of Pharmacy Kathog Jawalaji, India
  • Vinay Pandit Department of Pharmaceutical Analysis and Quality Assurance, Laureate Institute of Pharmacy Kathog Jawalaji, India
  • Mahendra Singh Ashawat Department of Pharmaceutical Analysis and Quality Assurance, Laureate Institute of Pharmacy Kathog Jawalaji, India

Abstract

A simple, sensitive, economic and specific reverse phase liquid chromatographic method was developed for the simultaneous estimation of Emtricitabine and Ritonavir in bulk drug. Chromatographic conditions consisted of   C-18 Column (Shim-pack) 250 x 4.6 mm, particle size 5 µm , mobile phase combination of methanol and water (80:20), flow rate 1ml per minutes, run time 15 minutes and UV detection at 251nm. . The retention time for Emtricitabine and Ritonavir were found to be   3.25 and 7.8 min and average percentage recoveries 99.42% and 99.63% respectively. The validation parameters were found to comply with ICH guidelines. These methods can be further employed in future for the routine determination of Emtricitabine and Ritonavir in bulk drug and formulation.


Keyword: Emtricitabine, Ritonavir, RP-HPLC, accuracy and linearity.

Keywords: Emtricitabine, Ritonavir, RP-HPLC, accuracy and linearity

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Author Biographies

Aman Kapoor, Department of Pharmaceutical Analysis and Quality Assurance, Laureate Institute of Pharmacy Kathog Jawalaji, India

Department of Pharmaceutical Analysis and Quality Assurance, Laureate Institute of Pharmacy Kathog Jawalaji, India

Amar Deep Ankalgi, Department of Pharmaceutical Analysis and Quality Assurance, Laureate Institute of Pharmacy Kathog Jawalaji, India

Department of Pharmaceutical Analysis and Quality Assurance, Laureate Institute of Pharmacy Kathog Jawalaji, India

Upasana Thakur, Department of Pharmaceutical Analysis and Quality Assurance, Laureate Institute of Pharmacy Kathog Jawalaji, India

Department of Pharmaceutical Analysis and Quality Assurance, Laureate Institute of Pharmacy Kathog Jawalaji, India

Vinay Pandit, Department of Pharmaceutical Analysis and Quality Assurance, Laureate Institute of Pharmacy Kathog Jawalaji, India

Department of Pharmaceutical Analysis and Quality Assurance, Laureate Institute of Pharmacy Kathog Jawalaji, India

Mahendra Singh Ashawat, Department of Pharmaceutical Analysis and Quality Assurance, Laureate Institute of Pharmacy Kathog Jawalaji, India

Department of Pharmaceutical Analysis and Quality Assurance, Laureate Institute of Pharmacy Kathog Jawalaji, India

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1.
Kapoor A, Ankalgi AD, Thakur U, Pandit V, Ashawat MS. Method Development and Validation for Multicomponent Analysis of Emtricitabine and Ritonavir in Bulk Drug by RP-HPLC. JDDT [Internet]. 30Nov.2020 [cited 17Jan.2022];10(6):137-44. Available from: http://www.jddtonline.info/index.php/jddt/article/view/4400