Method Development and Validation for Estimation of Etifoxine in Capsule Dosage Form by Using RP-HPLC/UV
Abstract
A RP-HPLC/UV method was developed and validated to quantify the etifoxine in capsule dosage form. The chromatographic separation was carried out using a Hypersil ODS C18 column (250×4.6 mm, 5 μm) with a mobile phase consisting of an ammonium acetate buffer: acetonitrile in a volumetric ratio of 40:60%. The UV wavelength chosen for detection was at 255 nm. The flow rate was set at 1 ml/min. The retention time for etifoxine was determined to be 2.074 min. Linearity was detected within the concentration range of 7.5-45 μg/mL for etifoxine. The approach has been confirmed to be linear, accurate, precise, robust, and has established limits of detection and quantitation. The established procedure was uncomplicated, cost-effective, and suitable for the routine analysis of etifoxine in capsule dosage form.
Keywords:
Etifoxine, RP-HPLC, Method development, ValidationDOI
https://doi.org/10.22270/jddt.v14i7.6703References
Nuss P, Ferreri F, Bourin M. An update on the anxiolytic and neuroprotective properties of etifoxine: from brain GABA modulation to a whole-body mode of action. Neuropsychiatric Disease and Treatment. 2019; 3:1781-95. https://doi.org/10.2147/NDT.S200568 PMid:31308671 PMCid:PMC6615018
Choi YM, Kim KH. Etifoxine for pain patients with anxiety. The Korean journal of pain. 2015; 28(1):4. https://doi.org/10.3344/kjp.2015.28.1.4 PMid:25589941 PMCid:PMC4293506
Hamon A, Morel A, Hue B, Verleye M, Gillardin JM. The modulatory effects of the anxiolytic etifoxine on GABAA receptors are mediated by the β subunit. Neuropharmacology. 2003; 45 (3):293-303. https://doi.org/10.1016/S0028-3908(03)00187-4 PMid:12871647
Papadopoulos V, Baraldi M, Guilarte TR, Knudsen TB, Lacapère JJ, Lindemann P, Norenberg MD, Nutt D, Weizman A, Zhang MR, Gavish M. Translocator protein (18 kDa): new nomenclature for the peripheral-type benzodiazepine receptor based on its structure and molecular function. Trends in pharmacological sciences. 2006; 27(8):402-9. https://doi.org/10.1016/j.tips.2006.06.005 PMid:16822554
J. Pang, H. Li, L. Li, Determination of etifoxine hydrochloride in etifoxinehydrochloride capsules, Zhongguo Yaoxue Zazhi (Beijing, China). 2008; 43:1823-1826.
Djabrouhou N, Guermouche MH. Development of a stability-indicating HPLC method of etifoxine with characterization of degradation products by LC-MS/TOF, 1H and 13C NMR. Journal of Pharmaceutical and Biomedical Analysis. 2014; 100:11-20. https://doi.org/10.1016/j.jpba.2014.07.017 PMid:25117950
Sai KE, Srinivas M, Kumari BU, Sumalatha C, Madhavi A. Development and Validation of an HPLC Method for the Determination of Lobeglitazone in Bulk and in Tablet Formulation. International Journal of Pharmaceutical Investigation. 2024; 14(1). https://doi.org/10.5530/ijpi.14.1.26
Harshita D, Srinivas M, Kumari BU, Sumalatha C, Umadevi R. Establishment and Validation of a High-performance Liquid Chromatography Technique for Quantifying Dalbavancin in Injectable Formulations. Asian Journal of Pharmaceutical Research and Health Care. 2023; 15(4):385-92. https://doi.org/10.4103/ajprhc.ajprhc_112_23
Sumalatha Ch, Srinivas M, Jitendar KM, Development of a Robust and Reliable RP-HPLC Method for the Estimation of Finerenone in Tablet Dosage Form. International Journal of Drug Delivery Technology. 2024; 14(2):703-708. https://doi.org/10.25258/ijddt.14.2.15
ICH. Validation of analytical procedure: Methodology International Conference on Harmonization. ICH harmonised tripartite guideline - validation of analytical procedures: text and methodology Q2(R1). ICH, Geneva, Switzerland, 2005.
Published
Abstract Display: 251 
PDF Downloads: 302 PDF Downloads: 61 How to Cite
Issue
Section
Authors who publish with this journal agree to the following terms:
- Authors retain copyright and grant the journal right of first publication with the work simultaneously licensed under a Creative Commons Attribution-NonCommercial 4.0 International (CC BY-NC 4.0). that allows others to share the work with an acknowledgment of the work's authorship and initial publication in this journal.
- Authors are able to enter into separate, additional contractual arrangements for the non-exclusive distribution of the journal's published version of the work (e.g., post it to an institutional repository or publish it in a book), with an acknowledgment of its initial publication in this journal.
- Authors are permitted and encouraged to post their work online (e.g., in institutional repositories or on their website) prior to and during the submission process, as it can lead to productive exchanges, as well as earlier and greater citation of published work (See The Effect of Open Access).
How to Cite
.