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Abstract

Topical creams that contain multicomponent active ingredients with antifungal, antibacterial and anti-inflammatory activities are designed to treat skin infections caused by bacteria and fungi and also to inhibit inflammation produced from such infections. Amongst these agents are betamethasone proprionate, clotrimazole and neomycin sulfate, often used in topical fixed-dose-combination formulations. These drugs are best assayed by HPLC, which is not easily accessed. Three brands of creams marked - I, II and III containing betamethasone diproprionate, clotrimazole and neomycin sulfate as actives were evaluated. Clotrimazole and betamethasone were extracted from cream in basic medium using DCM. Residual neomycin sulfate in basic medium was quantified by deamination using ninhydrin reagent at 570 nm, while amount of clotrimazole and betamethasone in DCM were determined by simultaneous UV spectrophotometry at 240 nm and 300 nm. The amount of CTZ, BMS and NEO in creams ranged from 96.67±0.98 to 100.33±1.69 %, 94.67±1.99 to 98.00±1.67 and 97.60±1.67 (t = 1.624) to 99.67±0.84 respectively. Method validation showed linearity for BMS, CTZ and NEO for concentrations ranging from 2 - 50 µg mL-1 (R2 ? 0.9996). The slopes and intercepts of the regression equations were ? 0.0981 and ? -0.068 respectively, while calculated standard errors were ? 0.25. The Limits of detection (LOD) and quantification (LOQ) for all brands ranged from 0.99 to 3.49 and 3.2 to 11.21 ?g/mL-1respectively. The percentage recovery for BMS, CTZ and NEO in two brands ranged from 91.50±1.13 to 101.50±0.36%. Statistically, brands were adjudged to have no significant difference from amount of drugs stated on the label at 95% confidence level as the student’s t-test values were found satisfactory.

Keywords

Fixed-dose-combination, Topical cream, Betamethasone, Clotrimazole, Neomycin

Reference

  1. Fischer JG, Robin C. Anologue-based Drug Discovery. John wiley and Sons. 2006, Pp. 485.
  2. Chu CC, Chen KC, Diau GY. Tropical steroids treatment of phimosis in boys. In J. urol. Topical steroids treatment of Phimosis 1999; 162(3pt1):861-3.
  3. Moreno G, Corbalan J, Peneloza B, Pantoja T. Tropical corticosteroids for treating phimosis in boys. The Cochrane Database of systematic Reviews 2004; 9.CD008973.
  4. Crowley PD, Gallagha HC. Clotrimazole as a pharmaceutical; past, present and future. J APPl Microbiol. 2004. 177(3);611-7.
  5. Gabev E, Kasianowicz J, Abbott T, McLaughlin S. Binding of neomycin to phosphatidylinositol 4,4-biphosphate(P1P2). BBA-biomembranes. 1989; 979.1.105-12. doi: 10.1016/0005-2736(89)90529-4
  6. Zug KA; Warshaw EM; Fowler JJF; Malbach H1; Belsito Dl; Pratt M.D; Sasseville D; Storrs FJ; Tylor JS; Mathia CG; Deleo VA; Rietschel Rl; Marks J. Patch-test results of the North American contact Dermatitis Group 2005-2006. Dermatitis, 2009; 20(3); 149-60.
  7. Massaccesi M. Two-phase Titration of some Imidazole derivatives in pharmaceutical preparations; Analyst 1986; 111: 987-989. 
  8. Mahmood S;  Ahmad, Z.,  Aslam, M., Naeem, F., Hussain, A., Kuma, N. Method development and validation for the estimation and evaluation of clotrimazole (an-Antifungal Drug) in Tablet Preparation by UV-VIS Spectroscopy. Int. J. Pharm. Sci. Rev. Res., 2015; 32(2), 11, 55-58
  9. Kalshetti, S., Rao, P. K. , Development and validation of HPLC method for the quantification of clotrimazole in a gelatin film formulation , Future J. Pharm Sci. 2021; 7: 130 
  10. Ali MA, Amin MA, Abd Halim EM. Green RP-HPLC stability-indicating assay method for neomycin sulfate in the veterinary formulation. Egypt. J. Chem, 2022; 65 (11) 155 - 162 
  11. Manassra A, Khamis M, el-Dakiky M, Abdel-Qader Z, Al-Rimawi F. Simultaneous HPLC analysis of betamethasone and clotrimazole in cream formulations. Pharm Anal Acta, 2010;  1:113. doi:10.4172/2153-2435.1000113
  12. Kumar K.K.S., and Krishnaveni G. First derivation UV spectrophotometric method for the sulmultaneous estimation of neomycin and betamethasone in their combined dosage form. Int. J. Res Rev.Pharm App Sci. 2016, 6(1):138H386.
  13. Bachri M, Reveny J, Permata YM, Situmorang CEA. Validation of intersection absorption spectrum for simultaneous determination of betamethasone valerate and neomycin sulfate in cream. Rasayan J Chem. 2019;12(1):232–9. https://doi.org/10.31788/RJC.2019.1215013.
  14. Bachri M, Permata YM, Permadi R. Validation and simultaneous estimation of betamethasone valerate and neomycin sulfate cream by absorbance ratio spectrophotometry methods. Int Res J Pharm. 2019;10(2):48–52. https://doi.org/10.7897/2230-8407.100240. [Google Scholar]
  15. Sakur, AA and Zakri, DAL. A new selective colorimetric method coupled with a high-resolution UV method for the consecutive quantification of three drugs in semi-solid preparations. Heliyon. 2022 Oct; 8(10): e11003. doi: 10.1016/j.heliyon.2022.e11003
  16. Parmar, P. and Mehta, A., Development and validation of HPTLC method for the estimation of clotrimazole in bulk drug and tablet formulation. Indian J Pharm Sci. 2009; 71(4): 451–454.  doi: 10.4103/0250-474X.57299
  17. Sathwik, M., Vijay, Sai, Raghav, P., Shanta, Kumari, A., Abdul, Rahaman, S. k.; Development and validation of new analytical method for the estimation of beclomethasone dipropionate, clotrimazole and neomycin sulfate in bulk and pharmaceutical dosage forms, Indo global journal of pharmaceutical sciences., (2018);8(3): 88-91
  18. Permata, Y., Bachri, M.,  Reveny, J., Sibuea, FM. Formulation and quantitative analysis of betamethasone valerate and neomycin sulfate cream by high performance liquid chromatography and spectrophotometry, Open Access Maced J Med Sci . 2019, 14;7(22):3841-3846.  doi: 10.3889/oamjms.2019.516. 
  19. The British Pharmacopoeia Commission, Monographs on Medicinal and Pharmaceutical Substances Market Towers 1 Nine Elms Lane London SW8 5NQ, 2009. I & II, 3407-3413; 6433-6437
  20. The Pharmacopeia of the United States and The National Formulary, United States Pharmacopeial ?Convention, Rockville, USP 37–NF 32 (2014)., Rockville, n.d
  21.  Vaikosen NE, Ebeshi UB, Worlu RC. Spectroscopic fingerprinting of aminoglycosides and determination of neomycin sulphate through oxidative ion-pair complex formation using ammonium molybdate. Current Pharm Anal, 2019; 15 (5) 487 - 496.
  22. ICH. International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human use, ICH Harmonized Tripartite Guideline, ICH Q2A. Text on validation of analytical procedures, November 2005. (accessed: 22 July, 2020)
  23. Bohm AD, Stachel SC, Gowik P. Confirmatory method for the determination of  streptomycin in apples by LC-MS/MS. Anal. Chim. Acta., 672 (2010) 103-106. doi.org/10.1016/j.aca.2010.03.056
  24. Shrivastava A, Gupta BV. Methods for the determination of limit of detection and limit of quantitation of the analytical methods. Chron. Young Sci., 2 (2011) 21-25
  25. Karthik VV. Excipient used in the formulation of tablets. Res Rev: J Chem. 2016;5(2):143-154

Photo
Edebi N. Vaikosen
Corresponding author

Department of Pharmaceutical and Medicinal Chemistry, Faculty of Pharmacy, Niger Delta University, Wilberforce Island, Nigeria.

Photo
Ruth C. Worlu
Co-author

Department of Pharmaceutical and Medicinal Chemistry, Faculty of Pharmacy, Niger Delta University, Wilberforce Island, Nigeria.

Photo
Samuel J. Bunu
Co-author

Department of Pharmaceutical and Medicinal Chemistry, Faculty of Pharmacy, Niger Delta University, Wilberforce Island, Nigeria.

Photo
Ebiere Dode
Co-author

Department of Pharmaceutical and Medicinal Chemistry, Faculty of Pharmacy, Niger Delta University, Wilberforce Island, Nigeria.

Photo
Mary Doctor
Co-author

Department of Pharmaceutical and Medicinal Chemistry, Faculty of Pharmacy, Niger Delta University, Wilberforce Island, Nigeria.

Edebi N. Vaikosen*, Ruth C. Worlu, Samuel J. Bunu, Ebiere Dode, Mary Doctor, Liquid-Liquid Separation And Determination Of Betamethasone, Clotrimazole And Neomycin In Topical Cream By UV-Visible Spectrophotometry, Int. J. in Pharm. Sci., 2023, Vol 1, Issue 4, 170-179. https://doi.org/10.5281/zenodo.8114461

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