Author(s): Sai Gnaneswari Aluri, Mukthinuthalapati Mathrusri Annapurna

Email(s): mmukthin@gitam.edu

DOI: 10.52711/0974-360X.2022.00329   

Address: Sai Gnaneswari Aluri, Mukthinuthalapati Mathrusri Annapurna*
Department of Pharmaceutical Analysis, GITAM School of Pharmacy, Gandhi Institute of Technology and Management (Deemed to be University), Visakhapatnam, India.
*Corresponding Author

Published In:   Volume - 15,      Issue - 5,     Year - 2022


ABSTRACT:
Efavirenz is an active non-nucleoside reverse transcriptase inhibitor used for the treatment of human immunodeficiency virus (HIV) type 1. A simple and validated new stability indicating RP-UFLC method has been developed for the estimation of Efavirenz in pharmaceutical dosage forms i. e. tablets. Shimadzu UFLC system (PDA detector) with Zorbox C18 column was chosen for the chromatographic study with flow rate 1.2 mL/min (UV detection at 252 nm). Beer-Lambert’s law was obeyed over a concentration range 0.05-160 µg/mL. The linear regression equation was found to be y = 44317x + 8491.1 (R2 = 0.9993). The LOD and LOQ was found to be 0.0142 and 0.0429 µg/mL respectively. Stress degradation studies were performed and the method was validated as per ICH guidelines. The proposed method is simple, precise, accurate and robust and can be applied for the quantification of Efavirenz formulations.


Cite this article:
Sai Gnaneswari Aluri, Mukthinuthalapati Mathrusri Annapurna. New stability indicating RP-UFLC method for the quantification of Efavirenz in pharmaceutical dosage forms. Research Journal of Pharmacy and Technology. 2022; 15(5):1981-8. doi: 10.52711/0974-360X.2022.00329

Cite(Electronic):
Sai Gnaneswari Aluri, Mukthinuthalapati Mathrusri Annapurna. New stability indicating RP-UFLC method for the quantification of Efavirenz in pharmaceutical dosage forms. Research Journal of Pharmacy and Technology. 2022; 15(5):1981-8. doi: 10.52711/0974-360X.2022.00329   Available on: https://rjptonline.org/AbstractView.aspx?PID=2022-15-5-11


REFERENCES:
1.    Treisman GJ, Soudry O. Neuropsychiatric Effects of HIV Antiviral Medications. Drug Safety. 2016; 39 (10): 945-957.
2.    Srivastava P, Moorthy GS, Gross R, Barrett JS. A sensitive and selective liquid chromatography/tandem mass spectrometry method for quantitative analysis of Efavirenz in human plasma. PLoS One. 2013; 8(6): e63305.
3.    Amara AB, Else LJ, Tjia J, Olagunju A, Puls RL, Khoo S, Back DJ. A validated method for quantification of Efavirenz in dried blood spots using high-performance liquid chromatography-mass spectrometry. Ther Drug Monit. 2015; 37(2): 220-228.
4.    Olagunju A, Bolaji OO, Amara A, Waitt C, Else L, Soyinka J, Adeagbo B, Adejuyigbe E, Siccardi M, Back D, Owen A, Khoo S. Development, validation and clinical application of a novel method for the quantification of Efavirenz in dried breast milk spots using LC-MS/MS. J Antimicrob Chemother. 2015; 70 (2): 555-561.
5.    Reddy NP, Padmavathi Y, Mounika P, Anjali A. FTIR spectroscopy for estimation of Efavirenz in raw material and tablet dosage form. Int. Current Pharmaceutical J. 2015; 4: 390-395
6.    Hamrapurkar P, Phale M, Shah N. Quantitative estimation of Efavirenz by high performance thin layer chromatography. J Young Pharm. 2009; 1(4): 359.
7.    Tamilselvi N, R. Arivukkarasu, Sasikala R, Shahanas, Shamina, Sreelakshmi Jayan. Development and validation of HPTLC method for the determination of Efavirenz in tablet dosage form. Research J. Pharm. and Tech. 2018; 11(3): 885-888.
8.    Lakshmi Sailaja A, Kishore Kumar K, Ravi Kumar DVR, Mohan Kumar C, Yugandhar NM, Srinubabu G. development and validation of a liquid chromatographic method for determination of Efavirenz in human plasma. Chromatographia, 2007; 65(5-6): 359-361.
9.    Saras-Nacenta M, López-Púa Y, Lípez-Cortés LF, Mallolas J, Gatell JM, Carné X. Determination of Efavirenz in human plasma by high-performance liquid chromatography with ultraviolet detection. J Chromatogr B Biomed Sci Appl. 2001; 763(1-2): 53-59.
10.    Heydari R, Rashidipour M, Naleini N. Determination of Efavirenz in plasma by dispersive liquid-liquid microextraction coupled to high-performance liquid chromatography. Curr Anal Chem. 2014; 10(2): 280-287.
11.    Gupta S, Kesarla R, Chotai N, Omri A. Development and validation of reversed-phase HPLC gradient method for the estimation of Efavirenz in plasma. PLoS One. 2017; 12(5): e0174777.
12.    Kamble RN, Mehta P. Innovare Academic Sciences. Development of simple HPLC method to estimate the blood plasma concentration of Efavirenz in rat after oral administration. Int. J Pharmacy and Pharmaceutical Sci. 2015; 7(7): 153-156.
13.    Kadam AA, Babu CJG, Permal RV, Channabasavaraj K, Mani TT. Development and validation of method for the quantitative estimation of Efavirenz in bulk and phrmaceutical dosage form. Am J PharmTech Res.2012; 2(1): 324-330.
14.    ICH Validation of analytical procedures: Text and methodology Q2 (R1), International Conference on Harmonization (2005).
15.    ICH Stability testing of new drug substances and products Q1A (R2), International Conference on Harmonization (2003).

Recomonded Articles:

Research Journal of Pharmacy and Technology (RJPT) is an international, peer-reviewed, multidisciplinary journal.... Read more >>>

RNI: CHHENG00387/33/1/2008-TC                     
DOI: 10.5958/0974-360X 

0.38
2018CiteScore
 
56th percentile
Powered by  Scopus


SCImago Journal & Country Rank


Recent Articles




Tags


Not Available