Author(s): K. Sai Priyanka, A. Sree Geetha, S. Amala, A. Sree Gayatri

Email(s): saipriyanka.k2995@gmail.com

DOI: 10.52711/2231-5675.2025.00030   

Address: K. Sai Priyanka1, A. Sree Geetha2, S. Amala3, A. Sree Gayatri4
1Assistant Professor, Aditya College of Pharmacy, Surampalem, Andhra Pradesh, India.
2,3,4Associate Professors, Aditya College of Pharmacy, Surampalem, Andhra Pradesh, India.
*Corresponding Author

Published In:   Volume - 15,      Issue - 3,     Year - 2024


ABSTRACT:
This study focused on advancement and validation of an ultra-high pressure liquid chromatography (UHPLC) method for concurrent determination of emtricitabine and efavirenz in drug formulations1. Leveraging the advanced capabilities of RP- UPLC technology1, this method offers superior resolution, reduced analysis time, and enhanced sensitivity compared to conventional chromatographic techniques. The chromatographic separation was performed on a ultra-performance Grace Smart C18 column, (4.6 X 50mm, 1.7µm) employing a grasdient elution with methanol as organic phase and phosphate buffer (pH 3.0) in the combination of 65:35 at a detection wavelength optimized at 260nm1. The run time of the method is about 5 minutes, ensuring rapid throughput for routine analysis. Validation was conducted in strict adherence to ICH Q2(R1) guidelines, encompassing parameters such as specificity, linearity, accuracy, repeatability and robustness. Notably, the method demonstrated exceptional linearity over the concentration ranges of 10–50µg/mL for emtricitabine and 20–100 µg/mL for efavirenz, correlation coefficients exceeding 0.9991. The method’s precision and accuracy were corroborated through intra- and inter-day studies, with recovery rates consistently ranging between 98–102%. LOD, LOQ were found within the limits. Robustness was evaluated under deliberate modifications obtained in different operating environments under critical conditions, affirming the reliability of the method in diverse operational settings1. Furthermore, the approach exhibited excellent selectivity, with no interference observed from excipients or degradation products. This innovative RP-UPLC method stands out as a powerful analytical tool, offering unparalleled speed and precision for the quality control of emtricitabine and efavirenz1.


Cite this article:
K. Sai Priyanka, A. Sree Geetha, S. Amala, A. Sree Gayatri. Concurrent Determination of Emtricitabine and Efavirenz in Tablet Formulations using a Robust UPLC Method. Asian Journal of Pharmaceutical Analysis. 2025; 15(3):191-6. doi: 10.52711/2231-5675.2025.00030

Cite(Electronic):
K. Sai Priyanka, A. Sree Geetha, S. Amala, A. Sree Gayatri. Concurrent Determination of Emtricitabine and Efavirenz in Tablet Formulations using a Robust UPLC Method. Asian Journal of Pharmaceutical Analysis. 2025; 15(3):191-6. doi: 10.52711/2231-5675.2025.00030   Available on: https://ajpaonline.com/AbstractView.aspx?PID=2024-15-3-6


REFERENCE:
1.    Tiwari, Ravi Yadav, Avinash K., V. Vaidya, P.A. Sathe, Deepali Gangrade. Development and validation of UPLC method for emtricitabine, tenofovir and efavirenz in pharmaceutical preparation. Analytical chemistry An Indian Journal. 2010;9(2).  
2.    https://go.drugbank.com/drugs/DB00879
3.    G. Ramya Kumari, N. C. Deepika, Krishnamurthy Bhat et.al. Simultaneous estimation of emitricitabine, efavirenz, tenofovir disproxil fumarate by chemometry and reverse phase-high performance liquid chromatography
4.    https://go.drugbank.com/drugs/DB00625
5.    Bhargavi, Desaraju, et al. Method development and validation for related impurities of efavirenz by RP-HPLC method. Analytical Chemistry Letters. 2017; 7(5): 737-747
6.    Devrukhakar, Prashant S., et al. A validated stability-indicating RP-HPLC method for the simultaneous determination of tenofovir, emtricitabine, and a efavirenz and statistical approach to determine the effect of variables. International Scholarly Research Notices 2013.
7.    Induri, Madhusudhanareddy, Bhagavan Raju Mantripragada, and Rajendra Prasad Yejella. Development and validation of a HPTLC method for simultaneous estimation of efavirenz and lamivudine in pharmaceutical formulations. World Journal of Pharmaceutical Sciences.  2016: 189-194.
8.    Addanki, Swetha, and B. Ramya Kuber. A new stability indicating RP-UPLC method for simultaneous estimation of Doravirine, Lamivudine and Tenofovir disoproxil fumarate in bulk and their combined pharmaceutical formulation. Future Journal of Pharmaceutical Sciences.  2021; 7: 1-14.
9.    Satya Venkata Sakuntala, M., A. Lakshmana Rao, and M. William Carey. Stability- indicating method development and validation for the concurrent determination of darunavir, cobicistat, emtricitabine and tenofovir alafenamide by UPLC in bulk and tablet dosage forms. Future Journal of Pharmaceutical Sciences. 2021; 7(1): 1-10.
10.    Skoog, Douglas A. West, Donald M.; Holler, F. James; Crouch, Stanley R. Fundamentals of Analytical Chemistry. Belmont: Brooks/Cole, Cengage Learning. 2014: 1.
11.    Ramaswamy, Arun, and Anton Smith Arul Gnana Dhas. Development and validation of analytical method for quantitation of Emtricitabine, Tenofovir, Efavirenz based on HPLC" Arabian Journal of Chemistry. 2018; 11(2): 275-281.
12.    Chengalva, Prasanthi, and Madhavi Kuchana. Development and Validation of Ultra Performance Liquid Chromatographic Method for the Simultaneous Estimation of Lamivudine, Tenofovir Disoproxil Fumarate, Doravirine and Efavirenzin Bulk and Pharmaceutical Formulations. Indian Journal of Pharmaceutical Sciences.  2020; 82(6).
13.    Willard H, Meritt L.L and Dean Settle. Instrumental Methods of Analysis, 7th edition, CBS Publishers and Distributors, New Delhi. 1986: 592-600.
14.    Kenneth A. Connors, Textbook of Pharmaceutical Analysis, 3rd edition, Wiley Publisher.
15.    B.K. Sharma, Instrumental Method of Chemical Analysis, Krishna Prakashan Media p Ltd. 1999
16.    Beckett A.H and Stenlake J.B. Practical Pharmaceutical Chemistry, 4th edition, CBS Publishers and Distributors, New Delhi. 2007; 3: 307-312.
17.    Mallepelli, Srivani, Sreelatha Kamera, and Achaiah Garlapati. Simultaneous Estimation of Lamivudine, Didanosine and Efavirenz in Bulk and their Formulation by UPLC. International Journal of Pharmaceutical Investigation. 2022; 12(2).
18.    Dadi, Vamsi, and G. Sowjanya. Development and validation of UPLC method for simultaneous estimation of Darunavir, Cobicistat, Emtricitabine and Tenofovir alafenamide in bulk drug and pharmaceutical dosage form. Research Journal of Pharmacy and Technology. 2023; 16(5): 2336-2342.
19.    Konidala, Sathish Kumar, et al. Novel RP-UPLC method development and validation for simultaneous quantification of emtricitabine, tenofovir and efavirenz in bulk and tablet dosage forms. Research Journal of Pharmacy and Technology. 2022; 15(7): 3141-3146
20.    Anindita Behera, Aurobinda Parida, Amit Kumar Meher, Dannana Gowri Sankar, Swapan Kumar Moitra, Sudam Chandra Si. Development and Validation of Spectrophotometric method for determination of Emtricitabine and Tenofovir Disoproxil Fumarate in Bulk and Tablet dosage form. International Journal of PharmTech Research. 2011; 3(3): 1874-1882.
21.    Anindita Behera, Aurobinda Parida, Amit Kumar Meher, Dannana Gowri Sankar, Swapan Kumar Moitra, Sudam Chandra. Development and validation of spectroscopic method for determination of Emtricitabine and Tenofovir alafenamide in bulk drug and Tablet dosage form. International Journal of Pharm Tech Research. 2011; 3(3): 1874-1882.


Recomonded Articles:

Author(s): Hamid Khan, Javed Ali

DOI: 10.5958/2231-5675.2017.00020.5         Access: Open Access Read More

Author(s): Pankaj Bhamare, Rupal Dubey, Neeraj Upmanyu, Pothuvan Umadoss

DOI: 10.5958/2231-5675.2021.00001.6         Access: Open Access Read More

Author(s): S. Subramanya Raj Urs, Bindu M., Ramyashree D., Sowmya K. N.

DOI: 10.5958/2231-5675.2020.00034.4         Access: Open Access Read More

Author(s): Shobha Rani G, Lohita M, Jaya Preethi P, Madhavi R, Sunisitha B, Mounika D

DOI:         Access: Open Access Read More

Author(s): Shinde Ganesh S., P. S. Rao, R. S. Jadhav, Piyusha Kolhe, Diksha Athare

DOI: 10.5958/2231-5675.2021.00009.0         Access: Open Access Read More

Author(s): Sri Lakshmi D, Jane T Jacob, Srinivasa Sastry D, Satyanarayana D

DOI: 10.5958/2231-5675.2017.00005.9         Access: Open Access Read More

Author(s): B. Thangabalan, M. Salomi, N. Sunitha, S. Manohar Babu

DOI:         Access: Open Access Read More

Author(s): Paras Virani, Rajanit Sojitra, Hasumati Raj, Vineet Jain

DOI: 10.5958/2231-5675.2015.00025.3         Access: Open Access Read More

Author(s): Kirthi A, Shanmugam R, Mohana Lakshmi S , Ashok Kumar CK, Padmini K, Shanti Prathyusha M, Shilpa V

DOI:         Access: Open Access Read More

Author(s): Khushboo Patel*, Dhara Patel, Jaya Dwivedi, Priyanka Newal, Dhananjay Meshram

DOI: 10.5958/2231-5675.2017.00039.4         Access: Open Access Read More

Author(s): Prashanthi. Y, Tentu Nageswara Rao, Yellapu Srinivas

DOI: 10.5958/2231-5675.2018.00034.0         Access: Open Access Read More

Author(s): Amitkumar J. Vyas, Chirag D. Jadav, Ajay I. Patel, Ashok B. Patel, Sunny R. Shah, Devang Sheth, Sandip Dholakia

DOI: 10.52711/2231-5675.2023.00022         Access: Open Access Read More

Asian Journal of Pharmaceutical Analysis (AJPA) is an international, peer-reviewed journal, devoted to pharmaceutical analysis...... Read more >>>

RNI: Not Available                     
DOI: 10.5958/2231–5675 


Recent Articles




Tags