SIMULTANEOUS ASSAYS OF METFORMIN HCL AND GLIBENCLAMIDE MIXTURE USING TWO ANALYTICAL METHODS OF SPECTROPHOTOMETRY

Authors

  • MUCHLISYAM BACHRI Department of Chemistry, Faculty of Pharmacy, Universitas Sumatera Utara, USU Campus, Padang Bulan, Medan, 20155, Indonesia

DOI:

https://doi.org/10.22159/ijap.2019v11i6.34022

Keywords:

AUC, Glibenclamide, Metformin HCl, MWS, Spectrophotometry methods, Validation

Abstract

Objective: Area Under Curve method (AUC) and the Multiple Wavelength Spectrophotometric (MWS) method are practice and simple methods for simultaneous assays of Metformin HCl and Glibenclamide on the tablet dosage form.

Methods: The AUC method is measured for the absorption spectrum with a concentration 4 mg/l Metformin HCl by calculating the area spectrum at wavelength 230-240 nm and the absorption spectrum with a concentration 8.7 mg/l Glibenclamide by calculating the area at wavelength 225-235 nm. The MWS by determining the absorption spectrum and the five wavelength points for the absorption value at 225 nm, 229.4 nm, 236.6 nm, 233 nm, and 243 nm and calculated using matrix operations.

Results: The validation test of the AUC method for Metformin HCl obtained accuracy = 99.35%, linearity = 0.9881, precision = 0.39%, LOD = 0.4459 mg/l. LOQ = 1.4864 mg/l and for Glibenclamide obtained accuracy = 100.79%, linearity = 0.9993, precision = 0.65%, LOD=0.4372 mg/l, LOQ = 1.4072 mg/l and the MWS method for Metformin HCl obtained accuracy = 100.76%, linearity 0.9949,  precision = 0.65%, LOD = 0.9103 mg/l, LOQ = 3.0431 mg/l, and for Glibenclamide with accuracy = 100.07%, linearity = 0.9993. precision = 0.36%, LOD = 0.9205 mg/l. LOQ = 3.0431 mg/l , and appropriate the requirements of ICH guidelines.

Conclusion: These Methods successively applied to determine of Metformin HCl and Glibenclamide mixture in tablet dosage form and fulfill the validation requirements.

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References

Gunawan SG. Pharmacology and therapy. 5th ed. Jakarta: Balai Publisher; 2005.

Finkel R, Cubeddu LX, Clark MA. Insulin and oral hypoglycemic drugs, In: Lippincott’s Illustrated reviews: Pharmacology. 4th ed. Florida: Lippincott Williams and Wilkin; 2009.

Moffat AC, Osselton MD, Widdop B, Galichet LY. Clarke’s analysis of drugs and poisons. 4th ed. London: Pharmaceutical Press; 2011.

Government of Indonesia. Indonesian Pharmacopoeia. 5th ed. Jakarta: Indonesian Health Ministry; 2014.

Gedawy A, Al-Salami H, Dass CR. Development and validation of a new analytical HPLC method for simultaneous determination of the antidiabetic drugs, metformin, and gliclazide. J Food Drug Anal 2019;27:315-22.

Chaudhary J, Jain A, Saini V. Simultaneous estimation of multicomponent formulations UV-visible spectroscopy: an overview. IRJP 2011;2:81-3.

Adriani F, Bachri M, Sinaga SM. Development and validation of double divisor ratio spectra derivative spectrophotometry method for ternary mixture of guaifenesin, dextromethorphan hbr, and diphenhydramine hcl in tablet dosage form. AJCPR 2018;11:1-3.

Muchlisyam, Sudarmi, Caroline C. Mean centering of ratio spectra method for the analysis of theophylline and ephedrine hcl mixture in tablet. AJCPR 2018;11:218-23.

Muchlisyam , Pardede TR, Satiawan R. Determination of simultaneous sulfamethoxazole and trimethoprim by ultraviolet spectrophotometry with mean centering of ratio spectra. Asian J Pharm Clin Res 2018;11 Special Issue 1:62-9.

Ganesh K, Akash G, Preeti K. Simultaneous determination of metformin and glibenclamide by ultra-violet spectrophotometry. Int Res J Pharm 2018;9:211-4.

Chavhan BR, Patil PB, Bavaskar SR, Barhate SD. Development and validation of analytical method for simultaneous estimation of glibenclamide and metformin hcl in bulk and tablets using u. v.–visible spectroscopy. WJPR 2015;4:1257-66.

Patil SS, Bonde CG. Development and validation of analytical method for simultaneous estimation of glibenclamide and metformin hcl in bulk and tablets using u. v.–visible spectroscopy. Int J ChemTech Res 2009;1:905-9.

Umadevi N, Mounika CH, Babu IS. Spectrophotometric method development and validation for the estimation of glibenclamide in pure form and in dosage form. IJPSR 2014;5:4925-8.

Attia KAM, Elabasawy NM, Abolmagd E. Simultaneous equation and area under curve spectrophotometric methods for estimation of cefaclor; in presence of its acid induced degradation product. Future J Pharm Sci 2017;30:1-5.

Ilango K, Kumar SPS. Simultaneous determination of olmesartan medoxomil and hydrochlorothiazide by area under curve and dual wavelength spectrophotometric methods. J Pharm Sci Res 2012;4:1946–9.

Karajgi SR, Tanveer AR, Kalyane NV. Simultaneous determination of artemether and lumefantrine by area under curve U. V. spectrophotometric method. J Pharm Sci Res 2016;8:506-11.

Nasution LR, Bachri M, Putra EDL. Simultaneous estimation of isoniazid and pyridoxine hydrochloride in tablet dosage form by spectrophotometry ultraviolet with area under curve method. AJCPR 2018;11:124-6.

Zainuddin M. Application of multiple wavelength method in spectrophotometric multicomponent analysis of a mixture of phenylbutazone and methampyrone. Ind Pharm Mag 1999;10:217-28.

U.S. Food and drug administration, analytical procedures, and methods validation for drugs and biologics; 2015. Available from: http://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/default.htm [Last accessed on 05 Apr 2019]

Ermer J, Miller JH. Method validation in pharmaceutical analysis. A guide to best practice. Weinheim: Wiley-Vch Verlag GmBH and Co. KGaA; 2005. p. 171.

Harmita F. Implementation guidelines for method validation and method of calculation. Ind Pharm Mag Jakarta 2004;1:18-20.

Published

07-11-2019

How to Cite

BACHRI, M. (2019). SIMULTANEOUS ASSAYS OF METFORMIN HCL AND GLIBENCLAMIDE MIXTURE USING TWO ANALYTICAL METHODS OF SPECTROPHOTOMETRY. International Journal of Applied Pharmaceutics, 11(6), 139–146. https://doi.org/10.22159/ijap.2019v11i6.34022

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Original Article(s)