Optimization and validation of an analytical method for the estimation of methotrexate in rabbit plasma

Hafiz Rashid Hussain; Sajid Bashir; Daulat Haleem Khan; Irum Shahzadi; Sheikh Abdur Rashid; Muhammad Hashim Khan; Zaineb Abdullah; Asif Mahmood; Muhammad Sarfraz

doi:10.36721/PJPS.2022.35.1.SUP.267-272.1

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Optimization and validation of an analytical method for the estimation of methotrexate in rabbit plasma

Author(s)

Hafiz Rashid Hussain College of Pharmacy, University of Sargodha,Sargodha,Pakistan

Sajid Bashir College of Pharmacy, University of Sargodha,Sargodha,Pakistan

Daulat Haleem Khan Department of Pharmacy, Lahore College of Pharmaceutical Sciences,Lahore,Pakistan

Irum Shahzadi Department of Biotechnology, COMSATS University Islamabad,Abbottabad campus, Abbottabad,Pakistan

Sheikh Abdur Rashid Faculty of Pharmacy, Gomal University,Dera Ismail Khan,Pakistan

Muhammad Hashim Khan Department of Pharmacy, Gomal center of biotechnology and biochemistry, University of Agriculture Dera Ismail Khan,,Pakistan

Zaineb Abdullah Department of Pharmacy, Lahore College of Pharmaceutical Sciences,Lahore,Pakistan

Asif Mahmood Department of Pharmacy, University of Lahore,Lahore,Pakistan

Muhammad Sarfraz College of Pharmacy, University of Sargodha,Sargodha,Pakistan

Abstract

Methotrexate (MTX) is an anticancer drug used for the treatment of various cancers and autoimmune diseases. In this study, High Performance Liquid Chromatography (HPLC) method was developed and validated for the estimation of MTX in rabbit plasma with high estimation rate and recovery. Various validation parameters like, sensitivity, sample recovery, accuracy and precision analysis were studied. The pre-saturated reversed C18 end capped HPLC column was used to separate MTX present in rabbit plasma. A solvent mixture of 100mM phosphate buffer pH 7.4 and acetonitrile (92:8 percent v/v) was employed as the mobile phase. Analysis was carried out at ? max 303 nm and retention time of MTX was found 5.32 min. During the method development and validation ICHQ2 (R1) guidelines were strictly followed. Developed method was found excellent in terms of recovery of MTX from plasma samples (98.6%). It is obvious from the current study that the developed HPLC method can be utilized to analyze the level of MTX in patients. Furthermore, the cost of the developed method for the determination of MTX would be very low as compared to the previously reported methods.

Publication Details

Page(s) 267-272

DOI 10.36721/PJPS.2022.35.1.SUP.267-272.1

Published Journal: Pakistan Journal of Pharmaceutical Sciences, Volume: 35, Issue: SUP1, Year: 2022

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Keywords

HPLC method development, Methotrexate, estimation of MTX in plasma

References

Agata SM,Harrington DJ SM,Clin SM .2019 .Laboratory assessment of folate (vitamin B 9) status. , 71(11) : 949-956.

Beg S,Jain A,Kaur R,Panda SS,Katare OP,Singh B .2016 .QbD-driven development and validation of an efficient bioanalytical UPLC method for estimation of olmesartan medoxomil. J. Liq. Chromatogr. Relat. Technol., 39 : 587-597.

Begas E,Papandreou C,Tsakalof A,Daliani D,Papatsibas G,Asprodini E .2014 .Simple and reliable HPLC method for the monitoring of methotrexate in osteosarcoma patients. J. Chromatogr. Sci., 52 : 590-595.

Cho YC,Park W,Kang JM,Ryu DS,Park Y,Seo JW,Koh YG,Park JH,Shin JH .2021 .Newly developed N-butyl cyanoacrylate (EG glue) for arterial embolization: A preclinical study in rabbit renal artery. Macromol. Res., 29 : 178-184.

Cronstein BN,Aune TM .2020 .Methotrexate and its mechanisms of action in inflammatory arthritis. Nat. Rev. Rheumatol., 16 : 145-154.

De Abreu CC,Pires Rosa PC,Da Costa Aguiar Alves B,Ajaime Azzalis L,De Souza Gehrke F,Pereira EC,Berlanga Campos Junqueira V,Ferreira Perazzo F,Affonso Fonseca FL F .2015 .Development and validation of HPLC method to determination of Methotrexate in children oncologic patients. Eur. Rev. Med, 19 : 1373-1380.

Demirbolat GM,Aktas E,Coskun GP,Erdogan O,Cevik O .2021 .New approach to formulate methotrexate-loaded niosomes: In vitro characterization and cellular effectiveness. J. Pharm. Innov., : 1-16.

Eftekhari M,Akrami M,Gheibi M,Azizi-Toupkanloo H,Fathollahi-Fard AM,Tian G .2020 .Cadmium and copper heavy metal treatment from water resources by high-performance folic acid-graphene oxide nanocomposite adsorbent and evaluation of adsorptive mechanism using computational intelligence, isotherm, kinetic, and thermodynamic analyses. Environ. Sci. Pollut, 27 : 43999-44021.

Estève MA,Devictor-Pierre B,Galy G,André N,Coze C,Lacarelle B,Bernard JL,Monjanel-Mouterde S .2006 .Severe acute toxicity associated with high-dose methotrexate (MTX) therapy: Use of therapeutic drug monitoring and test-dose to guide carboxypeptidase G2 rescue and MTX continuation. Eur. J. Clin. Pharmacol, 63 : 39-42.

Giri BR,Kim JS,Park JH,Jin SG,Kim KS,Ud Din F,Choi HG,Kim DW .2021 .Improved bioavailability and high photostability of methotrexate by spray-dried surface-attached solid dispersion with an aqueous medium. Pharmaceutics, 13 : 1-14.

Guichard N,Guillarme D,Bonnabry P,FleurySouverain S P .2017 .Antineoplastic drugs and their analysis: a state of the art review. Analyst, 142 : 2273-2321.

Jain A,Beg S,Saini S,Sharma T,Katare OP,Singh B .2019 .Application of chemometric approach for QbDEnabled development and validation of an RP-HPLC method for estimation of methotrexate. J. Liq. Chromatogr. Relat. Technol., 42 : 502-512.

K. Khurana R,Beg S,Lal D,Katare OP,Singh B .2015 .Analytical quality by design approach for development of a validated bioanalytical UPLC method of docetaxel trihydrate. Curr. Pharm. Anal., 11 : 180-192.

Karami F,Ranjbar S,Ghasemi Y,Negahdaripour M Y .2019 .Analytical methodologies for determination of methotrexate and its metabolites in pharmaceutical, biological and environmental samples. J. Pharm. Anal, 9(6) : 373-391.

Kumar V,Bhutani H,Singh S H .2007 .ICH guidance in practice: Validated stability-indicating HPLC method for simultaneous determination of ampicillin and cloxacillin in combination drug products. J. Pharm. Biomed. Anal., 43 : 769-773.

Li YD,Li Y,Liang NS,Yang F,Kuang ZP .2015 .A reversed-phase high performance liquid chromatography method for quantification of methotrexate in cancer patients serum. J. Chromatogr. B, 1002 : 107-112.

Michail K,Moneeb MS K .2011 .Determination of methotrexate and indomethacin in urine using SPE-LCDAD after derivatization. J. Pharm. Biomed. Anal, 55 : 317-324.

Myers CE,Lippman ME,Elliot HM,Chabner BA .1975 .Competitive protein binding assay for methotrexate. Proc. Natl. Acad. Sci., 72 : 3683-3686.

Patel A,Burns E,Burkemper NM .2018 .Methotrexate use in allergic contact dermatitis: A retrospective study. Contact Dermatitis, 78 : 194-198.

Steven HYW .2017 .Liquid chromatography and other methodologies for therapeutic drug monitoring and toxicology. In: Liquid Chromatography and other Methodologies For Therapeutic Drug Monitoring and Toxicology, : 39-78.

Uchiyama M,Jimi S,Takamatsu Y,Tamura K,Hara S K .2012 .Simple and sensitive HPLC method for the fluorometric determination of methotrexate and its major metabolites in human plasma by post-column photochemical reaction. Biomed. Chromatogr, 26 : 76-80.

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