ANALYTICAL METHOD OPTIMIZATION AND VALIDATION OF GLIBENCLAMIDE AND METFORMIN HYDROCHLORIDE IN DIABETIC HERBS PRODUCT BY THIN-LAYER CHROMATOGRAPHY-DENSITOMETRY
Objective: This study aimed to develop and validate an analytical method using thin-layer chromatography (TLC)-densitometry for detecting the
presence of glibenclamide and metformin hydrochloride in herbal diabetic products.
Methods: The jamu samples were extracted using methanol, followed by analysis using TLC-densitometry with methanol-aquades-glacial acetic acid
(9:1:0.25) as the mobile phase at a wavelength of 237 nm.
Results: From the validation results, the correlation coefficients for glibenclamide and metformin hydrochloride were determined to be 0.9998
and 0.9981, respectively. The limits of detection and quantitation for glibenclamide were 49.97 μg/mL and 66.55 μg/mL, respectively, while those
of metformin hydrochloride were 74.75 μg/mL and 249.25 μg/mL, respectively. The method developed in this study met the criteria of selectivity,
accuracy, and precision. From seven jamu samples tested, four tested positive for glibenclamide, with sample 1=4.9522%, sample 2=4.1495%, sample
3=4.2578%, and sample 4=4.9412%.
Conclusion: None of the jamu samples contained metformin hydrochloride.
The Ministry of Health; 2017.
2. Sari LO. Utilization of traditional medicine with consideration of the
benefits and safety pemanfaatan obat tradisional dengan pertimbangan
manfaat dan keamanannya. Majalah Ilmu Kefarmasian 2006;3:1-7.
3. Ministry of Health, Republic of Indonesia. Regulation Number 007
in 2012 Concerning Registration of Traditional Medicine. Indonesia:
Ministry of Health Republic of Indonesia; 2012.
4. Syaripudin M. Analysis of Corticosteroid in Aching Aches Analisis
Kortikosteroid Dalam Jamu Pegal Linu. Depok: Faculty of Mathematics
and Sciences of Universitas Indonesia; 1997.
5. Adriyani Y. Optimization and Validation of Piroxicam, Prednisone, and
Naproxen Analysis Methods in Gout Herbs by TLC-densitometry and
their Application in Several Samples. Depok: Faculty of Pharmacy of
Universitas Indonesia; 2013.
6. Jayanti R, Aprilia H, Lukmayani Y. Qualitative Analysis of
Glibenclamide Checmical Drugs in Diabetes Herbal Preparations on
the Market. Indonesia: Prosiding Penelitian SPeSIA Unisba; 2015.
7. Gabhe S, Mahadik K, Potawale S, Thati A. Development and Validation
of Chromatographic Methods for Simultaneous Quantification of
Drugs in Bulk and in their Formulations. Hamburg: Anchor Academic
8. Moffat AC, Osselton MD, Widdop B. Clarke’s Analysis of Drugs and
Poisons. London: Pharmaceutical Press; 2007.
9. Harmita. Physicochemical Analysis. Depok: Department of Pharmacy,
Faculty of Mathematics and Science Universitas Indonesia; 2006.
10. Krausse OS. Good Analytical Method Validation Practice Deriving
Acceptance Criteria for the AMV Protocol. Part II. Germany: Bayer
Health Care Coorporation; 2003. p. 31-47.
11. Riyanto. Validation and Verification of Test Methods: In Accordance
with ISO/IEC 17025 Testing and Calibration Laboratories. Yogyakarta:
Penerbit Deepublish; 2014.
12. Bouchaib I, Mohamed S, El Mestafa EH, Sanae A, Taoufiq S.
A statistical approach based on the total error concept for validation
the bioanalytical method: Application to the spectrophotometric
determination of traces amount of acetaminophen in human plasma. Int
J Pharm Pharm Sci 2014;6:413-21.
13. Ravichandran V, Shalini S, Sundram KM, Rajak H. Validation of
analytical methods-strategies and importance. Int J Pharm Pharm Sci
This work is licensed under a Creative Commons Attribution 4.0 International License.