Share This Article:

Effect of Acid, Base and Time on Different Brands of Glimepiride

Abstract PP. 1-5
DOI: 10.4236/oalib.1100744    1,562 Downloads   2,076 Views   Citations

ABSTRACT

The objective of this study is to develop the degradation studies of different brands of glimepiride available in market. Forced degradation is a powerful tool used routinely in pharmaceutical development in order to develop stability-indicating methods that lead to quality stability data and to understand the degradation pathways of the drug substances and drugs. Glimepiride is a medium- to long-acting sulfonylurea antidiabetic drug as it is the most prescribed oral antihyper glycaemic agent indicated to treat type 2 diabetes mellitus. Its mode of action is to increase insulin production by the pancreas. This is not used for type 1 diabetes because in type 1 diabetes the pancreas is not able to produce insulin. Glimepiride was subjected to different stress conditions as per (ICH) International Conference on Harmonization guidelines. Distilled water was used as solvents and the amount of drug was calculated after degradation by taking absorbance at 200 nm. According to the assay limit of USP specified that the content should not be less than 95% and not more than 105% of labelled amount. On basic pH brand A, and E showed degradation after the addition of 0.1 N base while other brands degraded as base has no impact on glimepiride concentration. On addition of 0.1 N HCl only brand E showed heavy degradation. After 48 hours the absorbance of all brands are different compared with initial absorbance which shows degradation of all brands.

Conflicts of Interest

The authors declare no conflicts of interest.

Cite this paper

Naveed, S. , Qamar, H. , Jawaid, W. and Bokhari, U. (2014) Effect of Acid, Base and Time on Different Brands of Glimepiride. Open Access Library Journal, 1, 1-5. doi: 10.4236/oalib.1100744.

References

[1] Singh, R. and Rehman, Z. (2012) Current Trends in Forced Degradation Study of Pharmaceutical Product Development. Journal of Pharmaceutical Education and Research, 3, 54-63.
[2] Zhou, L., Mao, B., Novak, T. and Ge, Z. (2007) Impurity Profile Tracking for Act Pharmaceutical Ingredients: Case Reports. Journal of Pharmaceutical and Biomedical Analysis, 44, 421-429.
http://dx.doi.org/10.1016/j.jpba.2006.11.004
[3] ICH Q3B (R2) (2006) Impurities in New Drug Substances and Products (Step 4). International Conference on Harmonization, 86-95.
[4] Ahuja, S. (1998) Impurities Evaluation of Pharmaceuticals. Marcel Dekker, New York.
[5] Lakshmi, K.S., Rajesh, T., Sharma, S. and Lakshmi, S. (2009) Development and Validation of Liquid Chromatographic and UV Derivative Spectrophotometric Methods for the Determination of Metformin, Pioglitazone and Glimepiride in Pharmaceutical Formulations. Der Pharma Chemica, 1, 238-246.
[6] Lehr, K.H. and Damm, P. (1990) Simultaneous Determination of the Sulphonylurea Glimepiride and Its Metabolites in Human Serum and Urine by High-Performance Liquid Chromatography after Precolumn Derivatization. Journal of Chromatography B: Biomedical Sciences and Applications, 526, 407-505.
http://dx.doi.org/10.1016/S0378-4347(00)82531-1
[7] Adithya, P., Vijayalakshmi, M., Rama Krishna, U.V. and Nihar Reddy, K. (2012) Stability Indicating Spectrophotometric Method for the Estimation of Glimepiride in Bulk and Various Marketed Brands of Tablets. Inventi Rapid: Pharm Analysis & Quality Assurance, 4, 1-5.
[8] Khan, M.A., Sinha, S., Vartak, S., Bhartiya, A. and Kumar, S. (2005) LC Determination of Glimepiride and Its Related Impurities. Journal of Pharmaceutical and Biomedical Analysis, 39, 928-43.
http://dx.doi.org/10.1016/j.jpba.2005.06.007
[9] Kovarikova, P., Klimes, J., Dohnal, J. and Tisovska, L. (2004) HPLC Study of Limepiride under Hydrolytic Stress Conditions. Journal of Pharmaceutical and Biomedical Analysis, 36, 205-209.
http://dx.doi.org/10.1016/j.jpba.2004.05.005
[10] Sengupta, P., Bhaumik, U., Ghosh, A., Kanti Sarkar, A. and Chatterjee, B. (2009) LC-MS-MS Development and Validation for Simultaneous Quantitation of Metformin, Glimepiride, and Pioglitazone in Human Plasma and Its Application to a Bioequivalence Study. Chromatographia, 69, 1243-1250.
http://dx.doi.org/10.1365/s10337-009-1056-5
[11] Prveenkumar Reddy, B, Boopathy D, Bibin Mathew, Prakash M, Perumal P, (2010) Method Development and Validation of Simultaneous Determination of Pioglitazone and Glimepiride in Pharmaceutical Dosage form by RP-HPLC. International Journal of ChemTech Research, 2, 50-53.
[12] Altinoz, S. and Tekeli, D. (2001) Analysis of Glimepiride by Using Derivative UV Spectrometric Method. Journal of Pharmaceutical and Biomedical Analysis, 24, 507-515.
http://dx.doi.org/10.1016/S0731-7085(00)00445-3
[13] Food and Drug Administration, HHS (2003) International Conference on Harmonisation; Stability Data Package for Registration Applications in Climatic Zones III and IV; Stability Testing of New Drug Substances and Products; availability. Federal Register Notices, 68, 65717-65718.
[14] Naveed, S., Waheed, N. and Nazeer, S. (2014) Degradation Studies of Ampicillin in API and Formulations. Journal of Applied Pharmaceutical Science, 6, 314-321.
[15] Naveed, S., Naseem, Y., Samie, S., Khan, S. and Ramzan, S. (2014) Degradation Study of Five Different Brands of Ciprofloxacin Using UV-Visible Spectrophotometer and Their Comparative Study. IRJP, 5, 189-190.
[16] Naveed, S., Shafiq, A., Khan, M., Jamal, M., Zafar, H., et al. (2014) Degradation Study of Available Brands of Metformin in Karachi Using UV Spectrophotometer. Journal of Diabetes Metabolism, 5, 328.
http://dx.doi.org/10.4172/2155-6156.1000328

  
comments powered by Disqus

Copyright © 2019 by authors and Scientific Research Publishing Inc.

Creative Commons License

This work and the related PDF file are licensed under a Creative Commons Attribution 4.0 International License.