Author(s):
Rubi Shaheen, S. H. Rizwan
Email(s):
rubishaheen18@gmail.com
DOI:
10.5958/0974-4150.2020.00039.5 
Address:
Rubi Shaheen1*, S. H. Rizwan2
1PG Student, Department of Pharmaceutical Analysis, Deccan School of Pharmacy, Hyderabad, Telangana, India.
2Professor, Department of Pharmaceutical Analysis, Deccan School of Pharmacy, Hyderabad, Telangana, India.
*Corresponding Author
Published In:
Volume - 13,
Issue - 3,
Year - 2020
ABSTRACT:
Emtricitabine and Tenofovir disoproxil fumarate simultaneously estimated in bulk and combined dosage form by high performance liquid chromatography (HPLC) which is simple, specific, accurate and economical method. Separation using this method was achieved on a phenomenex C18 (50mm x 2.1mm ID) 1.8µm, using mobile phase sodium phosphate: acetonitrile: methanol at a ratio of 50:30:20 eluted at a flow rate of 1 ml/min. The retention time for Emtricitabine and Tenofovir disoproxil fumarate is found to be 2.3 min and 3.5 min. Quantitation was achieve with photo diode array detector at wavelength of 270 nm based on peak area with the linear calibration curve at concentration of 50-150 µg/ml for emtricitabine and 25-75 µg/ml for Tenofovir disoproxil fumarate. % Recovery was found to be 101.9% and 100.5%. The LOD were found to be 0.795 µg/ml and 2.4 µg/ml and LOQ was found to be 2.4 µg/ml for Emtricitabine and 7.0 µg/ml for Tenofovir disoproxil fumarate. The above drug combination is subjected to hydrolytic, photolytic and thermal stress environment. It was observed that Emtricitabine mostly degrade under dry heat (thermal degradation) where as Tenofovir disoproxil fumarate degrades mostly when subjected to peroxide degradation. The method was found to be specific and can be employed for the routine quality control analysis of both the drugs individually and in combined dosage form.
Cite this article:
Rubi Shaheen, S. H. Rizwan. A Stability Indicating Method for estimating Emtricitabine and Tenofovir disoproxil fumarate simultaneously in Bulk and Combined dosage form by RP-HPLC. Asian J. Research Chem. 2020; 13(3):203-208. doi: 10.5958/0974-4150.2020.00039.5
Cite(Electronic):
Rubi Shaheen, S. H. Rizwan. A Stability Indicating Method for estimating Emtricitabine and Tenofovir disoproxil fumarate simultaneously in Bulk and Combined dosage form by RP-HPLC. Asian J. Research Chem. 2020; 13(3):203-208. doi: 10.5958/0974-4150.2020.00039.5 Available on: https://ajrconline.org/AbstractView.aspx?PID=2020-13-3-9
REFERENCE:
1. Drug profile for Emtricitabine. Available from http://www.drugbank.ca/drugs/DB00879
2. Drug profile of Tenofovir disoproxil fumarate. Available from http://www.drugbank.ca/drugs/DB09299
3. E.Littler, X.Zhou. Deoxyribonucleic Acid Viruses: Antivirals for Herpes viruses and Hepatitis B Virus. Comprehensive Medicinal Chemistry II. 2007; 7:295-327.
4. MD Abdul Sattar and Suneetha Achanta. Analytical Method Development and Validation for Determination of Emtricitabine and Tenofovir Disoproxil Fumarate Using Reverse Phase HPLC Method in Bulk and Tablet Dosage Form. J. Pharm. Sci.& Res. 2018; 10(5):1207-1212.
5. Vishnu P. Choudhari, Sanket R. Parekar, Subhash G. Development and Validation of UV- Visible Spectrophotometric Baseline Manipulation Method for Simultaneous Quantitation of Tenofovir Disoproxil Fumarate and Emtricitabine in Pharmaceutical Dosage Form. Journal of Spectroscopy. 2013; 146580: 6.
6. Anna Pratima G. Nikalje, Zibran Syed, DileepBhosale. A Simple, Reliable, Rapid and Stability Indicating Ultra Performance Liquid Chromatographic Method for the Quantitation of Emtricitabine. Am. J. PharmTech Res. 2013; 3(1): 621-632.
7. Budagam lavanya, Perumalla Hariprasad, Allumellu Venkatapraveen, Dudipala Prasannalakshmi, Maram Ramireddy. Simultaneous estimation of emtricitabine and tenofovir disproxil fumerate by HPLC method. Der Pharmacia Lettre. 2012; 4(6): 1855-1862.
8. International Conference on Harmonisation (ICH). In: Q2 (R1) Validation of Analytical Procedures: Text and Methodology. Geneva, 2005.