A validated stability indicating LC-MS compatible RP-HPLC assay and dissolution methods for marketed formulation Stribild

  • U Harini Department of Pharmaceutical Analysis and Quality Assurance, A.U. College of Pharmaceutical Sciences, Andhra University, Visakhapatnam, Andhra Pradesh, India.
  • AKM Pawar Department of Pharmaceutical Analysis and Quality Assurance, A.U. College of Pharmaceutical Sciences, Andhra University, Visakhapatnam, Andhra Pradesh, India.
DOI https://doi.org/10.22270/jddt.v8i6.2037

Abstract

Objective: The prime objective of the current work is to develop a simple, rapid, efficient, economical and stability indicating LC-MS (liquid chromatography–mass spectroscopy) compatible RP - HPLC (reverse phase – high performance liquid chromatography) method for the analysis of emtricitabine (EMT), tenofovir disoproxil fumarate (TDF), cobicistat (COB) and elvitegravir (ELV) in bulk, marketed formulation (Stribild) and in In-vitro dissolution method.


Method: The chromatography was achieved on Unisol C18 column (250 × 4.0 mm, 3 µ) with a mobile phase combination of acetate buffer (adjusted with dilute glacial acetic acid to pH 4) and acetonitrile in gradient mode at a flow rate of 1mL/min and the detection was performed at 260 nm using PDA (photo diode array) detector. Forced degradation studies were performed and the % degradation under various stress conditions was calculated. The developed RP-HPLC method was applied for Stribild tablets to study the dissolution profile.


Results: The retention times for emtricitabine, tenofovir disoproxil fumarate, cobicistat and elvitegravir were 5.7, 12.1, 16.3 and 19.4 min respectively. The % degradation was below 20% which is within the limits. The percent drug release was found to meet USP specification, i.e. not less than 80% of amount of labeled drug EMT, TDF, COB and ELV dissolved in 30min.


Conclusion: The method was validated as per ICH guidelines and all the validation parameters were within the compendial requirements. The proposed method can be successfully adopted for the analysis of Stribild tablets in pharmaceutical industries.


Keywords: Stribild, emtricitabine, tenofovir disoproxil fumarate, cobicistat, elvitegravir

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Author Biographies

U Harini, Department of Pharmaceutical Analysis and Quality Assurance, A.U. College of Pharmaceutical Sciences, Andhra University, Visakhapatnam, Andhra Pradesh, India.

Department of Pharmaceutical Analysis and Quality Assurance, A.U. College of Pharmaceutical Sciences, Andhra University, Visakhapatnam, Andhra Pradesh, India.

AKM Pawar, Department of Pharmaceutical Analysis and Quality Assurance, A.U. College of Pharmaceutical Sciences, Andhra University, Visakhapatnam, Andhra Pradesh, India.

Department of Pharmaceutical Analysis and Quality Assurance, A.U. College of Pharmaceutical Sciences, Andhra University, Visakhapatnam, Andhra Pradesh, India.

References

1) Gilead Sciences “New Drug Applications for Cobicistat and Elvitegravir for HIV Therapy Accepted by U.S. FDA”, April 21, 2014.
2) Aids info Drug Database, Elvitegravir/Cobicistat/Emtricitabine / Tenofovir Disoproxil Fumarate. [Online], Available at: https://aidsinfo.nih.gov/
3) Highlights of prescribing information. Stribild® (elvitegravir, cobicistat, emtricitabine, tenofovir disoproxil fumarate) tablets, for oral use Initial U.S. Approval: 2012.
4) Vegesna Swetha, S. V. U. M. Prasad, Y. Asha Rani, Analytical method development and validation for simultaneous estimation of Cobicistat and Elvitegravir by using RP-HPLC in pure and Pharmaceutical Dosage Forms. Asian Journal of Pharmaceutical Analysis. 2017; 7(3):151-158.
5) Raveendra Babu V.V, Pankaj K. Sharma, Singhvi. I, Simultaneous Estimation of Tenofovir Disoproxil Fumarate, Cobicistat, Emtricitabine and Elvitegravir by Liquid Chromatography in Bulk and Tablet Dosage Form, Asian Journal of Chemistry, 2014; 26(18):6233-6237.
6) Khaleel. N, Abdul Rahaman. S K, A Validated Stability Indicating RP-HPLC Method for Simultaneous Estimation of Tenofovir Disoproxil Fumarate, Cobicistat, Emtricitabine and Elvitegravir in Bulk and Pharmaceutical Dosage Form, International Journal of Pharmacy, 2015; 5(3):991-1002.
7) Putchakayala Purnachandra Rao, Dondeti Mogili Reddy and D. Ramachandran, Stability Indicating HPLC Method for Simultaneous Estimation of Emtricitabine, Tenofovir Disoproxyl Fumarate, Cobicistat and Elvitegravir in Pharmaceutical Dosage Form, World Journal of Pharmaceutical Sciences, 2014; 2(12):1822-1829.
8) Chinnalalaiah Runja, Pigili Ravi Kumar and Srinivasa Rao Avanapu, A Validated Stability Indicating RP-HPLC Method for the Determination of Emtricitabine, Tenofovir Disoproxil Fumarate, Elvitegravir and Cobicistat in Pharmaceutical Dosage Form, Journal of Chromatographic Science, 2016, doi: 10.1093/chromsci/bmw004.
9) Mallikarjuna rao and Gowri Sankar Dannana, Simultaneous estimation of Emtricitabine, Elvetigravir, Cobicistat and Tenofovir by RP-HPLC, Indian Journal of Pharmaceutical Education and Research, 2016; 50(1):205-211.
10) Raghu Ram Jampala, V. Kiran Kumar, Appala Raju Nemala, Development and Application of Liquid Chromatographic Method for Simultaneous Determination of Elvitegravir, Tenofovir Disoproxil Fumarate, Emtricitabine and Cobicistat in Fixed Dosage Form, Pharmaceutical Methods, 2014; 5(1):7-13.
11) Srinivas Ganta, Vidyadhara. S, A New Simple Analytical Method for Simultaneous Estimation of Cobicistat and Elvitegravir by RP-HPLC-PDA in Their Tablet Dosage Forms, Journal of Global Trends in Pharmaceutical Sciences, 2017; 8(1):3584-3589.
12) Mangamma. K. et al, Development and Validation of a New RP-HPLC Method for Simultaneous Estimation of Emtricitabine, Tenofovir, Cobicistat, Elvitegravir and Its Comparison with A Reported Method, Indo American Journal of Pharmaceutical Sciences, 2017; 4(06):1599-1612
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How to Cite
1.
Harini U, Pawar A. A validated stability indicating LC-MS compatible RP-HPLC assay and dissolution methods for marketed formulation Stribild. JDDT [Internet]. 15Nov.2018 [cited 30May2020];8(6):159-70. Available from: http://jddtonline.info/index.php/jddt/article/view/2037
Issue
Vol 8 No 6 (2018): VOLUME 8, ISSUE 6 Nov-Dec 2018
Section
Research
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