Development and validation of novel method for simultaneous estimation of Atovaquone and Mefloquine hydrochloride in bulk drug using RP-HPLC

Sanyam  Sharma; Amar Deep  Ankalgi; Rahul Sharma; Arti Devi; Shammy Jindal; Kamya Goyal

doi:10.18231/j.joapr.2020.v.8.i.3.48.54

Authors

Sanyam Sharma Department of Pharmaceutical Analysis and Quality Assurance, Laureate Institute of Pharmacy, Kathog, Jawalamukhi, Himachal Pradesh-176031
Amar Deep Ankalgi Department of Pharmaceutical Analysis and Quality Assurance, Laureate Institute of Pharmacy, Kathog, Jawalamukhi, Himachal Pradesh-176031
Rahul Sharma Department of Pharmaceutical Analysis and Quality Assurance, Laureate Institute of Pharmacy, Kathog, Jawalamukhi, Himachal Pradesh-176031,
Arti Devi Department of Pharmaceutical Analysis and Quality Assurance, Laureate Institute of Pharmacy, Kathog, Jawalamukhi, Himachal Pradesh-176031
Shammy Jindal Department of Pharmaceutics, Laureate Institute of Pharmacy, Kathog, Jawalamukhi, Himachal Pradesh-176031
Kamya Goyal Laureate Institute of Pharmacy, Kathog, Jawalamukhi, HP

DOI:

https://doi.org/10.18231/j.joapr.2020.v.8.i.3.48.54

Abstract

Atovaquone and Mefloquine hydrochloride are well known anti-malarial drugs. Literature survey reveals that there was no method available for the selected drug combination. In this way, here an endeavour has been made to develop simple, precise, fast method for simultaneous estimation of atovaquone and mefloquine hydrochloride in bulk drug by using RP-HPLC method. The method was carried out by using gradient HPLC on C18 column using Shimadzu prominence LC 20 AD and mobile phase comprised of Methanol:ACN:Water in the ratio of 85:7.5:7.5 (pH 2.9 was adjusted with OPA). The method was performed with 10µl injection volume. The UV detection was done at 231nm.The retention times of atovaquone and mefloquine hydrochloride were 7.6 and 2.6 min respectively. The proposed method was validated according to ICH guidelines. The validation parameters were linearity, accuracy, precision (inter-day, intra-day and repeatability) and robustness etc. Linearity was in the range of 80-120µg/ml for atovaquone and 40-60µg/ml for mefloquine hydrochloride. The percent recoveries of both drugs were 99.99-100% and 92.05-99.09%. This method is suitable for the routine analysis of atovaquone and mefloquine hydrochloride in bulk drugs either individually or in mixture

Downloads

Download data is not yet available.

References

Bruce-Chwatt LJ. Malaria and its control: present situation and future prospects. Annu Rev Public Health 8, 75-110. (1987).

Antimalarial Drug Combination Therapy, Report of a WHO technical consultation http://archives.who.int/tbs/access/use_of_antimalarials2.pdf cited on 20 November 2019

Chattopadhyay R, Mahajan B, Kumar S. Assessment of safety of the major antimalarial drugs. Expert Opinion on Drug Safety. 6, 505-521 (2007).

Dhanawat M, Das N, Nagarwal R, Shrivastava S. Antimalarial Drug Development: Past to Present Scenario. Mini-Reviews Med. Chem., 9, 1447-1469 (2009).

Tripathi K. Essential of Medical Pharmacology 7 (2013).

Bruce-Chwatt LJ, Black RH, Canfield CJ, Clyde DF, Peters W, Wernsdorfer WH, World Health Organization. Chemotherapy of malaria. World Health Organization. 1986.

Fry M, Pudney M. Site of action of the antimalarial hydroxynaphthoquinone, 2-[trans-4-(4’-chlorophenyl) cyclohexyl]-3- hydroxy-1,4-naphthoquinone (566C80). Biochem. Pharmacol., 43, 1545-1553 (1992).

McKeage K, Scott L. Atovaquone/proguanil: a review of its use for the prophylaxis of Plasmodium falciparum malaria. Drugs 63, 597-623. (2003).

Winter RW, Kelly JX, Smilkstein MJ, Dodean R, Hinrichs D, Riscoe MK. Antimalarial quinolones: Synthesis, potency, and mechanistic studies. Exp. Parasitol., 118, 487-497 (2008).

Kessl JJ, Lange BB, Merbitz-Zahradnik T, Zwicker K, Hill P, Meunier B, Pálsdóttir H, Hunte C, Meshnick S, Trumpower BL. Molecular basis for atovaquone binding to the cytochrome bc1 complex. J. Biol. Chem., 278, 31312-31318 (2003).

Biagini GA, Viriyavejakul P, O’Neill PM, Bray PG, Ward SA. Functional characterization and target validation of alternative complex I of Plasmodium falciparum mitochondria. Antimicrob. Agents Chemother., 50, 1841-1851 (2006).

Ryley JF. The mode of action of proguanil and related antimalarial drugs. Br. J. Pharmacol. Chemother., 8, 424 (1953).

Varsha HC, Ajit AP, Kulkarni CG and Burade KB. Development and evaluation of spectrophotometric method for the estimation of Atovaquone in pharmaceutical dosage form. International Journal of Pharmaceutical Sciences and Research. 4, 3965-3970 (2013).

GlaxoSmithKline (June 2015). "Mepron". Drugs.com. Retrieved 22 (2016) cited 22 September 2019

Paul MA, McCarthy AE, Gibson N, Kenny G, Cook T, Gray G. The impact of Malarone® and primaquine on psychomotor performance. Aviat. Sp. Environ. Med., 74, 738-745 (2003).

Hudson AT. Atovaquone - a novel broad-spectrum anti-infective drug. Parasitol. Today, 9, 66-68 (1993).

National Centre for Biotechnology Information. "PubChem Compound Summary Mefloquine" PubChem, https://pubchem.ncbi.nlm.nih.gov/compound/4046. cited 21 May, 2020.

Marson BM, de Oliveira Vilhena R, de Souza Madeira CR, et al. Simultaneous quantification of artesunate and mefloquine in fixed-dose combination tablets by multivariate calibration with middle infrared spectroscopy and partial least squares regression. Malaria Journal. 15, 109. (2016)

Manikandan K, Lakshmi KS, Geetha Y, Sowmiya K, Saranya K. Method development and validation of artesunate and mefloquine hydrochloride in bulk and dosage form by HPTLC. J Chem Pharm Sci. 6, 155-60 (2013).

Tembhurkar NB, Chopade VV, Jadhav SB, Chaudhari PD. Development and Validation of Stability Indicating HPLC Assay Method for Determination of Mefloquine Hydrochloride in Bulk and Pharmaceutical Formulations. Journal of Pharmacy Research., 5, 4929-4933 (2012).

Jyothi K, Geetha A, Ajitha, Rao MVU, Ramarao N.Stability Indicating Method Development and Validation for Simultaneous Estimation of Mefloquine and Artesunate in Tablet Dosage Form. Scholars Academic Journal of Pharmacy Sch. Acad. J. Pharm., 3, 411-417 (2014).

ICH, Q2 Validation of Analytical Procedures: Text and Methodology. International Conference onHarmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use, ICH harmonized Tripartite Guideline. (2005) https://database.ich.org/sites/default/files/Q2_R1__Guideline.pdf cited 19 September 2019