Author(s):
Kalyani Sahare, Atul Hemke, Sandip Dhawale, Milind Umekar
Email(s):
atulhemke321@gmail.com
DOI:
10.5958/0974-360X.2021.00112.8 
Address:
Kalyani Sahare*, Atul Hemke, Sandip Dhawale, Milind Umekar
Department of Pharmaceutical Chemistry, Smt. Kishoritai Bhoyar College of Pharmacy, New Kamptee,
Nagpur, Maharashtra- 441002 (India).
*Corresponding Author
Published In:
Volume - 14,
Issue - 2,
Year - 2021
ABSTRACT:
The present research work describe development of simple, accurate and reliable UV-Spectrophotometric methods and dissolution test methods for Acotiamide hydrochloride hydratye. The spectrophotometric methods and dissolution test method was performed by subjecting drug and it’s formulation to various parameters. The development of UV-Spectrophotometric methods were carried out by using methanol followed by water as a solvent and absorbance measured at selected wavelength 219nm and 286nm for non-zero order And 303.6nm for first order. The correlation coefficient value found to be less than 1 for all developed UV-methods. The proposed method was validated as per ICH guidelines and estimation and recovery in formulation was found to be nearly 100% (% RSD not more than 2%). The dissolution test method was developed on the basis of solubility study of the Acotiamide hydrochloride hydrate different dissolution media of varying pH. The optimized dissolution parameter contains 900ml of Phosphate buffer pH 6.8 as dissolution medium, USP apparatus type-II at 100rpm. The % release obtained around 99.84% in 10 min. Hence the proposed spectrophotometric and dissolution test method can be applied successfully for the quality control of Acotiamide hydrochloride hydrate in marketed tablets.
Cite this article:
Kalyani Sahare, Atul Hemke, Sandip Dhawale, Milind Umekar. Development of UV-Spectrophotometric methods and Determination of dissolution profile of Acotiamide Hydrochloride Hydrate. Research J. Pharm. and Tech. 2021; 14(2):628-632. doi: 10.5958/0974-360X.2021.00112.8
Cite(Electronic):
Kalyani Sahare, Atul Hemke, Sandip Dhawale, Milind Umekar. Development of UV-Spectrophotometric methods and Determination of dissolution profile of Acotiamide Hydrochloride Hydrate. Research J. Pharm. and Tech. 2021; 14(2):628-632. doi: 10.5958/0974-360X.2021.00112.8 Available on: https://www.rjptonline.org/AbstractView.aspx?PID=2021-14-2-8
REFERENCES:
1. Technical brief 2009. Analytical method development and validation. Available from: https://www.particlesciences. com/news/technical-briefs/2009/analytic-method-development-%20and-validation.html
2. Compound summary of Acotiamide hydrochloride hydrate. Available from: https://pubchem.ncbi.nlm.nih.gov/compound/ Acotiamide-hydrochloride-hydrate
3. Attia K. A. M. et al. Spectrophotometric determination of Acotiamide hydrochloride tri-hydrate in the presence of its oxidative degradation product by different ratio spectra manipulating method. International Journal of Sciences. 2018; 5(3):46-50.
4. Imam P. S. et al. Chromogenic-visible-spectrophotometric quantification of Acotiamide in bulk drug and its formulation. World Journal of Pharmaceutical Research. 2017; 6 (17): 1261-1267.
5. Ojha S. D. et al. Development and validation of stability indicating RP-HPLC method for estimation of Acotiamide hydrochloride hydrate in tablet dosage form. Indo American Journal of Pharmaceutical Sciences. 2018; 5 (4): 2563-2571.
6. Chaudhari G. et al. Development and validation of stability indicating RP-HPLC method for Acotiamide hydrochloride hydrate in pharmaceutical dosage form. European Journal of Biomedical and Pharmaceutical Sciences. 2018; 5(5): 621-627.
7. Vani R. and Sunitha M. Analytical method development and validation for the determination of Acotiamide hydrochloride hydrate using reverse phase HPLC method in bulk and tablet dosage form. World Journal of Pharmacy and Pharmaceutical Sciences. 2017; 6 (10): 768-775.
8. Attia K. A. M. et al. spectrophotometric determination of Acotiamide hydrochloride tri-hydrate in the presence of its degradative product. The Journal of Biological and Chemical Luminescence. 2018; 1: 1-6.
9. Kalra K. Method development and validation of analytical procedure, quality control of herbal medicines and related areas. In Tech Europe, Shanghai. 2011: 1-6.
10. Kealey D. and Haines P. J. Instant notes analytical chemistry, Bios Scientific Publisher Ltd. 1st ed. 2002.
11. Kasture A. V. et al. Pharmaceutical analysis instrumental methods, vol-II, Nirali Publication, 2012.
12. Frank A. S. Handbook of instrumental techniques for analytical chemistry. National science foundation, Arlington, virginia, 1997.
13. Vijayraj S. et al. Analytical process of drug by ultraviolet (UV) spectroscopy: A review. International Journal of Pharmaceutical Research and Analysis. 2012; 2 (2): 72-78.
14. Wruster D. and Tylor P. Dissolution rates. Journal of Pharmaceutical Sciences. 1965; 54 (2): 169-175.
15. Demerturk E. and Oner L. In-vitro in-vivo correlation. Journal of Pharmaceutical Sciences. 2003; 1(28): 215-224.
16. FIP Guidelines for dissolution testing of solid oral products. Pharm Industries. 1981; 43: 334-343.
17. Prior A. et al. Current guidelines on comparison of dissolution profile.2007; 1: 617.
18. Cardot J. et al. In-vivo in vitro correlation importance. Dissolution Technologies. 2007; 14 (1):15-19
19. Analytical methods a statistical prospective on ICH Q2A and Q2B guidelines for validation of analytical methods. Bio Pharm International. 2006:1-6.