Development and Validation of RP-HPLC Method for Simultaneous Estimation of Emtricitabine and Tenofovir Disoproxil Fumarate in Bulk and Tablet Dosage Form

Authors

  • Nachiket S Dighe Department of Pharmaceutical Chemistry, Pravara Rural College of Pharmacy, Pravaranagar. Tal-Rahata, Dist.- Ahmednagar, 413736, India (MS)
  • Ganesh S Shinde Department of Pharmaceutical Chemistry, Pravara Rural College of Pharmacy, Pravaranagar. Tal-Rahata, Dist.- Ahmednagar, 413736, India (MS)
  • Sagar. D. Magar Department of Pharmaceutical Chemistry, Pravara Rural College of Pharmacy, Pravaranagar. Tal-Rahata, Dist.- Ahmednagar, 413736, India (MS)
  • Ankita V. Deodhe Department of Pharmaceutical Chemistry, Pravara Rural College of Pharmacy, Pravaranagar. Tal-Rahata, Dist.- Ahmednagar, 413736, India (MS)

Abstract

An analytical method was developed for estimation of Emtricitabine and Tenofovir Disoproxil Fumarate in drug product by using high performance liquid chromatography. The chromatographic separation was performed on column Cosmosil C18 (250mm x 4.6ID, Particle size: 5micron) using methanol: water (70:30 v/v) as mobile phase with flow rate of 0.8 ml/min. The detection was carried by using UV-300-M detector at 266 nm wavelength. The retention times of Emtricitabine and Tenofovir Disoproxil Fumarate were found to be 3.561 and 5.478 min respectively. Run time was observed as 5.54 min and 7.05 min respectively for Emtricitabine and Tenofovir Disoproxil Fumarate. Validation was performed as per ICH guidelines which include accuracy, precision, linearity, specificity, LOD, LOQ, ruggedness and robustness all of these were found within standard range as per ICH norms. Preparation of mobile phase is very simple & does not require lengthy procedure. Proposed method was found to be accurate and specific for routine quality control of pharmaceutical dosage form like bulk and tablet dosage form.

Keywords: Emtricitabine, Tenofovir Disoproxil Fumarate, HPLC, Validation.

DOI

https://doi.org/10.22270/jddt.v9i3-s.2952

Author Biographies

Nachiket S Dighe, Department of Pharmaceutical Chemistry, Pravara Rural College of Pharmacy, Pravaranagar. Tal-Rahata, Dist.- Ahmednagar, 413736, India (MS)

Department of Pharmaceutical Chemistry, Pravara Rural College of Pharmacy, Pravaranagar. Tal-Rahata, Dist.-  Ahmednagar, 413736, India (MS)

Ganesh S Shinde, Department of Pharmaceutical Chemistry, Pravara Rural College of Pharmacy, Pravaranagar. Tal-Rahata, Dist.- Ahmednagar, 413736, India (MS)

Department of Pharmaceutical Chemistry, Pravara Rural College of Pharmacy, Pravaranagar. Tal-Rahata, Dist.-  Ahmednagar, 413736, India (MS)

Sagar. D. Magar, Department of Pharmaceutical Chemistry, Pravara Rural College of Pharmacy, Pravaranagar. Tal-Rahata, Dist.- Ahmednagar, 413736, India (MS)

Department of Pharmaceutical Chemistry, Pravara Rural College of Pharmacy, Pravaranagar. Tal-Rahata, Dist.-  Ahmednagar, 413736, India (MS)

Ankita V. Deodhe, Department of Pharmaceutical Chemistry, Pravara Rural College of Pharmacy, Pravaranagar. Tal-Rahata, Dist.- Ahmednagar, 413736, India (MS)

Department of Pharmaceutical Chemistry, Pravara Rural College of Pharmacy, Pravaranagar. Tal-Rahata, Dist.-  Ahmednagar, 413736, India (MS)

Published

20-06-2019
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How to Cite

1.
Dighe NS, Shinde GS, Magar SD, Deodhe AV. Development and Validation of RP-HPLC Method for Simultaneous Estimation of Emtricitabine and Tenofovir Disoproxil Fumarate in Bulk and Tablet Dosage Form. J. Drug Delivery Ther. [Internet]. 2019 Jun. 20 [cited 2025 Mar. 18];9(3-s):693-8. Available from: https://jddtonline.info/index.php/jddt/article/view/2952

Issue

Vol. 9 No. 3-s (2019): Volume 9, Issue 3-s, May-June 2019 (Supplement Issue)

Section

Research

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How to Cite

1.
Dighe NS, Shinde GS, Magar SD, Deodhe AV. Development and Validation of RP-HPLC Method for Simultaneous Estimation of Emtricitabine and Tenofovir Disoproxil Fumarate in Bulk and Tablet Dosage Form. J. Drug Delivery Ther. [Internet]. 2019 Jun. 20 [cited 2025 Mar. 18];9(3-s):693-8. Available from: https://jddtonline.info/index.php/jddt/article/view/2952
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