Simultaneous determination of mometasone furoate and calcipotriol in a binary mixture by validated HPLC and chemometric-assisted UV spectrophotometric methods and identification of degradation products by LC-MS

سال انتشار: 1402
نوع سند: مقاله ژورنالی
زبان: انگلیسی
مشاهده: 141

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شناسه ملی سند علمی:

JR_IJBMS-26-1_006

تاریخ نمایه سازی: 8 دی 1401

چکیده مقاله:

Objective(s): A new binary mixture containing mometasone furoate (MF) and calcipotriol (CP) is suggested to manage psoriasis; since the combined stability profile of these drugs is poorly understood.Materials and Methods: Herein MF, CP, and their mixtures were subjected to various stress conditions. Also, stability-indicating HPLC was developed and validated according to ICH guidelines with Box-Behnken design. The degradation products (DPs) were predicted in silico and identified using LC-MS. The bioactivity and toxicity of DPs were studied using molecular docking and alamarBlue assay, respectively. Spectroscopic techniques of the first derivative, first-derivative ratio, and the mean-centering of ratio spectra were also used to determine MF and CP in the mixture because of spectra overlapping. Results: The major degradants for MF in alkaline conditions were DP۱, DP۲, and DP۳, while in thermal and UV conditions, only DP۱ was generated. CP gave one degradant in all conditions. No new impurity was observed in the MF and CP mixtures. The results of spectrophotometry showed good linearity in the range of ۴-۵۰ and ۲-۲۰ µg/ml, while linearity for HPLC was in the range of ۴–۵۰ and ۰.۵–۲.۵ µg/ml for MF and CP, respectively. Recovery was ۹۹.۶۱–۱۰۰.۳۸% for UV and ۱۰۰.۴% for HPLC methods of MF and ۱۰۰.۶–۱۰۱.۴% for UV and ۹۹.۵% for HPLC methods of CP.Conclusion: The developed methods can be used as simple, accurate, precise, and rapid techniques for routine quality control of MF and CP mixtures.

نویسندگان

Maryam Jahani

Department of Pharmaceutical Control, School of Pharmacy, Mashhad University of Medical Sciences, Mashhad, Iran

Maryam Akaberi

Department of Pharmacognosy, School of Pharmacy, Mashhad University of Medical Sciences, Mashhad, Iran

Tahereh Heidari

Department of Chemistry, Faculty of Sciences, Ferdowsi University of Mashhad, Mashhad, Iran

Hossein Kamali

Department of Pharmaceutics, School of Pharmacy, Mashhad University of Medical Sciences, Mashhad, Iran

Mozhgan Nejabat

Department of Medicinal Chemistry, School of Pharmacy, Mashhad University of Medical Sciences, Mashhad, Iran

Omid Rajabi

Department of Pharmaceutical Control, School of Pharmacy, Mashhad University of Medical Sciences, Mashhad, Iran

Farzin Hadizadeh

Biotechnology Research Center, Pharmaceutical Technology Institute, Mashhad University of Medical Sciences, Mashhad, Iran

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  • ۳.Aslankoc R, Savran M, Doğuç DK, Sevimli M, Tekin H, ...
  • Lawton S. Psoriasis presentations and potential treatment pathways. Practice Nursing ...
  • Gual A, Pau-Charles I, Molin S. Topical treatment for scalp ...
  • Elmets CA, Korman NJ, Prater EF, Wong EB, Rupani RN, ...
  • Kleyn EC, Morsman E, Griffin L, Wu JJ, Cm van ...
  • Ma L, Yang Q, Yang H, Wang G, Zheng M, ...
  • McCormack PL. Calcipotriol/betamethasone dipropionate. Drugs ۲۰۱۱; ۷۱: ۷۰۹-۷۳۰ ...
  • Svensson Å, Reidhav I, Gisslén H, Nordin P, Giös I. ...
  • Shinde G, Desai P, Shelke S, Patel R, Bangale G, ...
  • FDA/ICH. Guidance for industry. Q۸ Pharmaceutical development. ۲۰۰۶ ...
  • Xu Q. Advancing USP compendial methods for fixed dose combinations: ...
  • Davoodi J, Majidi S, Jahani M, Tayarani‐najaran Z, Golmohammadzadeh S, ...
  • Jahani M, Fazly Bazzaz BS, Akaberi M, Rajabi O, Hadizadeh ...
  • Tome T, Žigart N, Časar Z, Obreza A. Development and ...
  • El-Sayed HM, Hashem H. Quality by design strategy for simultaneous ...
  • Panchale WA, Bakal RL. First-order derivative spectrophotometric estimation of gemifloxacin ...
  • Victor N, Elfiky H, Badawey A, Abdelghany M. Simultaneous determination ...
  • Essam HM, Saad MN, Elzanfaly ES, Amer SM. Optimization and ...
  • Lotfy HM, Salem H, Abdelkawy M, Samir A. Spectrophotometric methods ...
  • Teng XW, Cutler DC, Davies NM. Degradation kinetics of mometasone ...
  • Sahasranaman S, Tang Y, Biniasz D, Hochhaus G. A sensitive ...
  • Teng XW, Foe K, Brown KF, Cutler DJ, Davies NM. ...
  • Ramzia I, Marwa A, Manal A, Enas H. Derivative, derivative ...
  • Shaikh KA, Patil AT. Stability-indicating HPLC method for the determination ...
  • Shaikh S, Muneera M, Thusleem O, Tahir M, Kondaguli AV. ...
  • Roy C, Chakrabarty J. Stability-indicating validated novel RP-HPLC method for ...
  • Singh M, Charde R, Charde MM. Determination of Calcipotriene, its ...
  • Roy C, Chakrabarty J, Ratti RR. Development and validation of ...
  • Badilli U, Amasya G, Özkan S, Tarimci N. Simultaneous determination ...
  • Ayers PW, Parr RG. Variational principles for describing chemical reactions: ...
  • Rignall A. ICHQ۱A (R۲) stability testing of new drug substance ...
  • Mohamed EH, Lotfy HM, Hegazy MA, Mowaka S. Different applications ...
  • Ganorkar A, Gupta K. Analytical Quality by Design: A mini ...
  • Guideline ICH. Validation of analytical procedures: Text and Methodology. Q۲ ...
  • Kumar P, Nagarajan A, Uchil PD. Analysis of cell viability ...
  • Salinas F, Nevado JB, Mansilla AE. A new spectrophotometric method ...
  • Vichare V, Choudhari VP, Reddy MV. Study of intrinsic stability ...
  • Iqbal J, Gupta A, Husain A. Photochemistry of clobetasol propionate, ...
  • Simonsen L, Høy G, Didriksen E, Persson J, Melchior N, ...
  • Li X, Wang J, Li G, Lin C, Zhang X, ...
  • Napoli JL, Koszewski NJ, Horst RL. (۱۴) Isolation and identification ...
  • Harvey D. Modern analytical chemistry: McGraw-Hill New York; ۲۰۰۰ ...
  • Mahmoodani F, Perera CO, Fedrizzi B, Abernethy G, Chen H. ...
  • Bundgaard H, Hansen J. Studies on the stability of corticosteroids ...
  • Foe K, Cheung HA, Tattam BN, Brown KF, Seale JP. ...
  • Yip Y, Po ALW, Irwin W. Kinetics of decomposition and ...
  • Mori M, Pimpinelli N, Giannotti B. Topical corticosteroids and unwanted ...
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  • Bhogadi R, Satyanarayana A, Rao NS, Arutla S, Reddy AM. ...
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