Analytical method development and validation for simultaneous estimation of mefloquine hydrochloride and artemether in bulk drug by simultaneous equation method
Keywords:Mefloquine hydrochloride, Artemether, Simultaneous Equation Method, Method Validation
The purpose of the research is to establish a fast, accurate, precise, and low-cost UV-Visible spectrophotometry method for the quantitative simultaneous estimation of mefloquine hydrochloride and artemether in bulk drug. The UV-Visible method employed was a simultaneous equation method. Ethanol was used as a solvent and therefore the absorption maxima (λ max) was found to be 229 nm and 209 nm for mefloquine hydrochloride and artemether. The linearity ranges of both drugs were 1-6 μg/mL and 100 – 350 μg/mL with a regression coefficient r2 ≥ 0.998 respectively. The method was validated for different parameters according to International Conference on Harmonization ICH Q2B guidelines. The average recovery for mefloquine hydrochloride was found to be 100 per cent and artemether 99.3 per cent. The method was also found precise and robust with a per cent relative standard deviation of less than 2. All the parameters result obtained within the limits. Therefore, the proposed method for the accurate quantitation of mefloquine hydrochloride and artemether in the bulk drug was successfully implemented.
Nogueira FHA, Goulart LDPL, César IDC, De Campos LMM, Pianetti GA. Development and validation of an HPLC method for mefloquine hydrochloride determination in tablet dosage form. J. AOAC Int., 94, 1089–93 (2011).
Goud VM, Deepika S, Gupta A, Sreekanth M, Swamy LK. A Review on Analytical methods for the determination of Artemether in Pharmaceutical Formulation. Asian J. Pharm. Anal., 10, 112 (2020).
Kalyankar TM, Kakade RB, Attar MS, Kamble AR. Simultaneous spectrophotometric estimation of artesunate and mefloquine. J. Chem., 2013, 5 (2013).
Karajgi S. R. TAR and KNV. Simultaneous Determination of Artemether and Lumefantrine by Area Under Curve UV Spectrophotometric Method. J. Pharm. Sci. Res., 8, 506–11 (2016).
Christian J, Shah P, Patel M, Patel K, Gandhi T. Optimizing derivatization conditions using an experimental design and simultaneous estimation of artemether and lumefantrine by ratio first order derivative spectrophotometric method. J. Taibah Univ. Sci., 11, 729–40 (2017).
Arun R, Smith A. Simultaneous HPLC-UV method for the estimation of artemether and lumefantrine in tablet dosage form. Int. J. Pharm. Biomed. Res., 2, 201–5 (2011).
Ahmad H, Khandelwal K, Pachauri SD, Gunjan S, Tripathi R, Dwivedi AK. HPLC analytical method for simultaneous estimation of mefloquine and clarithromycin. J. Biomater. Tissue Eng., 4, 567–72 (2014).
Vinodh M, Vinayak M, Pankaj P, Rahul K, Renita M. Analytical method development and validation for simultaneous estimation of artemether and lumefantrine in pure and pharmaceutical dosage form using RP-HPLC method. Malaysian J. Anal. Sci., 17, 348–58 (2013).
Habib R, Shoaib MH, Ahmed FR, Siddiqui F, Yousuf RI, Saleem T, Khan MZ. HPLC-UV method for simultaneous quantitation of artemether and lumefantrine in fixed dose combination orodispersible tablet formulation. Pak. J. Pharm. Sci., 33, 1561–7 (2020).
Rao A, Murthy R. A rapid spectrophotometric method for the determination of mefloquine hydrochloride. J. Pharm. Biomed., 27, 959–65 (2002).
“ICH Official web site : ICH”.: <https://www.ich.org/page/quality-guidelines>, cited 30 December, 2019.
How to Cite
Copyright (c) 2020 Mr. Amit Choudhary, Dr. Manish Sinha, Mrs. Kamya Goyal, Mrs. Arti Devi
This work is licensed under a Creative Commons Attribution-NonCommercial 4.0 International License.
In submitting an article to Journal of Applied Pharmaceutical Research (JOAPR) I certify that:
- I am authorized by my co-authors to enter into these arrangements.
- I warrant, on behalf of myself and my co-authors, that:
- the article is original, has not been formally published in any other peer-reviewed journal, is not under consideration by any other journal and does not infringe any existing copyright or any other third party rights;
- I am/we are the sole author(s) of the article and have full authority to enter into this agreement and in granting rights to JOAPR are not in breach of any other obligation;
- the article contains nothing that is unlawful, libellous, or which would, if published, constitute a breach of contract or of confidence or of commitment given to secrecy;
- I/we have taken due care to ensure the integrity of the article. To my/our - and currently accepted scientific - knowledge all statements contained in it purporting to be facts are true and any formula or instruction contained in the article will not, if followed accurately, cause any injury, illness or damage to the user.
- I, and all co-authors, agree that the article, if editorially accepted for publication, shall be licensed under the Creative Commons Attribution-NonCommercial 4.0 International License
- I, and all co-authors, agree that, if the article is editorially accepted for publication in Journal of Applied Pharmaceutical Research (JOAPR) data included in the article shall be made available under the Creative Commons 1.0 Public Domain Dedication waiver, unless otherwise stated. For the avoidance of doubt it is stated that sections 1, 2, and 3 of this license agreement shall apply and prevail.