STABILITY INDICATING UV SPECTROPHOTOMETRIC METHOD FOR DETERMINATION OF DRONEDARONE HYDROCHLORIDE
Abstract
The objective of this study was to develop stability UV method for estimation of Dronedarone Hydrochloride in tablet to compare % degradation of this drug determined by this UV method to HPTLC method reported by us earlier. Analysis of bulk as well as marketed tablet formulation by exposure to same degradative conditions was done and % degradation obtained by spectroscopy was determined. Method development and validation was done as per ICH guidelines. % degradation observed by both methods was comparable. The variation in the results of this drug estimated by HPTLC and spectrophotometric method was statistically insignificant. This suggests that the spectrophotometric method is suitable to determine stability profile. Hence a simple UV spectrophotometry can be used to monitor stability of Dronedarone Hydrochloride.
Keywords:
Dronedarone Hydrochloride, spectrophotometry, stability, Statistical study, HPTLCDOI
https://doi.org/10.25004/IJPSDR.2015.070121References
1. www.chemspider.com/imageview.aspx (Nov.2013).
2. www.rxlist.com/multaq.drug.htm (Nov 2013).
3. Pravalika K, Sudhakar M, Fathima A. Spectrophotometric estimation of Dronedarone hydrochloride in pharmaceutical dosage forms by using multivariate technique. World J Pharm Sci. 2013; 1(1):15-18.
4. Bolderman RW, Hermans JJ, Maessen JG. Determination of the class III antiarrhythmic drugs dronedarone and amiodarone, and their principal metabolites in plasma and myocardium by high-performance liquid chromatography and UV-detection. J Chromatogr B Analyt Technol Biomed Life Sci. 2009; 877: 1727-1735.
5. Patel A, Akhtar J. RP-HPLC method development and validation of Dronedarone Hydrochloride in its pure form and tablet dosage form. J. Chem. Pharm. Res. 2012; 4(4):2173-2179.
6. Patel D, Choudhury A. Development and validation of Dronedarone Hydrochloride in plasma by RP-HPLC method coupled with UV detector. Biomedical Analysis, Article ID - “Inventi: pba/47/12”, 2012.
7. Batuk D, Jadeja Y, Patel M, Jebaliya H, Karia D, Shah A. Method development and validation of a stability-indicating RP-HPLC method for the quantitative analysis of Dronedarone hydrochloride in pharmaceutical tablets. Sci Pharm. 2013; 81: 115-122.
8. Bhatt KK, Emanual MP, IshaniA. Development of a validated stability-indicating RPHPLC method for Dronedarone hydrochloride in pharmaceutical formulation. J Anal Bioanal Techniques 4: 165. doi:10.4172/2155-9872.1000161.
9. Rajyalakshmi C, Benjamin T, Rambabu C. Forced degradation study on Dronedarone and application of validated stability-indicating HPLC-UV method in stability testing of Dronedarone tablets. Der Pharma Chemica. 2013; 5(1):189-195.
10. Chhabra GS, Banerjee SK. Stability indicating assay method development and validation of dronedarone hydrochloride in its bulk form by RP-HPLC. Bulletin of Pharmaceutical Research 2013; 3(2):58-65.
11. Rao SP, Cholleti VK, Reddy RV. Stability-indicating UPLC method for determining related substances and degradants in dronedarone. J Chromatogr Sci. 2013 doi: 10.1093/chromsci/bmt097.
12. Dabhi B, Jebaliya H, Patel M, Jadeja Y, Karia D, shah A. HPTLC method for estimation of dronedarone hydrochloride in both bulk drug and pharmaceutical dosage. Int. J. Pharm. Sci. Rev. Res. 2012; 17(1): 48-51.
13. Xie C, Yang S, Zhong D, Dai X, Chen X. Simultaneous determination of dronedarone and its active metabolite debutyldronedarone in human plasma by liquid chromatography-tandem mass spectrometry: application to a pharmacokinetic study. J Chromatogr B Analyt Technol Biomed Life Sci. 2011 Oct 15; 879(28): 3071-5.
14. Jain PS, Bari PR, Girase DS, Kadtan DB, Ishi PL, Shinkar DA. Area under Curve Method Development and Validation for Estimation of Dronedarone in Bulk and Tablet Dosage Form. J. Pharm. Bio Sci. 2013; 2: 44-47.
15. Dabhi B, Jebaliya H, Jadeja Y, Patel M, Shah A and Karia D. Fast Stability Indicating UPLC Method for Quantitative Analysis of Dronedarone in Pharmaceutical Dosage Form: Force Degradation Study. Hindawi Publishing Corporation, ISRN Chromatography, 2014, 2014, Article ID 962130, http://dx.doi.org/10.1155/2014/962130.
16. Landge SB, Jadhav SA, Nimbalkar KP, Mali AC, Mathad VT. Stability Indicating RP-HPLC Method for the Determination of Dronedarone Hydrochloride and Its Potential Process-Related Impurities in Bulk Drug and Pharmaceutical Dosage Form. American Journal of Analytical Chemistry 2013; 4: 323-335.
17. Ahirrao VK, Patil CS, Bembalkar SR, Katariya MV, Sonnekar VS, MaratheRP, Nawale RB, Pawar RP. J. Chil. Stress degradation studies of dronedarone in pharmaceutical dosage form by a validated stability indicating LC method. Chem. Soc. 2012; 57(3): 1272-1276.
18. Kardile K, Damle MC, stability-indicating HPTLC method for quantitative estimation of Dronedarone hydrochloride in bulk and pharmaceutical dosage form. World journal of pharmacy and pharmaceutical sciences 2014; 3(6): 2163-2175.
19. Gupta SC, Kapoor VK, Fundamentals of mathematical statistics, 9th edition, S. Chand and Sons Educational Publishers, New Delhi, 1996, pp. 14.26.
2. www.rxlist.com/multaq.drug.htm (Nov 2013).
3. Pravalika K, Sudhakar M, Fathima A. Spectrophotometric estimation of Dronedarone hydrochloride in pharmaceutical dosage forms by using multivariate technique. World J Pharm Sci. 2013; 1(1):15-18.
4. Bolderman RW, Hermans JJ, Maessen JG. Determination of the class III antiarrhythmic drugs dronedarone and amiodarone, and their principal metabolites in plasma and myocardium by high-performance liquid chromatography and UV-detection. J Chromatogr B Analyt Technol Biomed Life Sci. 2009; 877: 1727-1735.
5. Patel A, Akhtar J. RP-HPLC method development and validation of Dronedarone Hydrochloride in its pure form and tablet dosage form. J. Chem. Pharm. Res. 2012; 4(4):2173-2179.
6. Patel D, Choudhury A. Development and validation of Dronedarone Hydrochloride in plasma by RP-HPLC method coupled with UV detector. Biomedical Analysis, Article ID - “Inventi: pba/47/12”, 2012.
7. Batuk D, Jadeja Y, Patel M, Jebaliya H, Karia D, Shah A. Method development and validation of a stability-indicating RP-HPLC method for the quantitative analysis of Dronedarone hydrochloride in pharmaceutical tablets. Sci Pharm. 2013; 81: 115-122.
8. Bhatt KK, Emanual MP, IshaniA. Development of a validated stability-indicating RPHPLC method for Dronedarone hydrochloride in pharmaceutical formulation. J Anal Bioanal Techniques 4: 165. doi:10.4172/2155-9872.1000161.
9. Rajyalakshmi C, Benjamin T, Rambabu C. Forced degradation study on Dronedarone and application of validated stability-indicating HPLC-UV method in stability testing of Dronedarone tablets. Der Pharma Chemica. 2013; 5(1):189-195.
10. Chhabra GS, Banerjee SK. Stability indicating assay method development and validation of dronedarone hydrochloride in its bulk form by RP-HPLC. Bulletin of Pharmaceutical Research 2013; 3(2):58-65.
11. Rao SP, Cholleti VK, Reddy RV. Stability-indicating UPLC method for determining related substances and degradants in dronedarone. J Chromatogr Sci. 2013 doi: 10.1093/chromsci/bmt097.
12. Dabhi B, Jebaliya H, Patel M, Jadeja Y, Karia D, shah A. HPTLC method for estimation of dronedarone hydrochloride in both bulk drug and pharmaceutical dosage. Int. J. Pharm. Sci. Rev. Res. 2012; 17(1): 48-51.
13. Xie C, Yang S, Zhong D, Dai X, Chen X. Simultaneous determination of dronedarone and its active metabolite debutyldronedarone in human plasma by liquid chromatography-tandem mass spectrometry: application to a pharmacokinetic study. J Chromatogr B Analyt Technol Biomed Life Sci. 2011 Oct 15; 879(28): 3071-5.
14. Jain PS, Bari PR, Girase DS, Kadtan DB, Ishi PL, Shinkar DA. Area under Curve Method Development and Validation for Estimation of Dronedarone in Bulk and Tablet Dosage Form. J. Pharm. Bio Sci. 2013; 2: 44-47.
15. Dabhi B, Jebaliya H, Jadeja Y, Patel M, Shah A and Karia D. Fast Stability Indicating UPLC Method for Quantitative Analysis of Dronedarone in Pharmaceutical Dosage Form: Force Degradation Study. Hindawi Publishing Corporation, ISRN Chromatography, 2014, 2014, Article ID 962130, http://dx.doi.org/10.1155/2014/962130.
16. Landge SB, Jadhav SA, Nimbalkar KP, Mali AC, Mathad VT. Stability Indicating RP-HPLC Method for the Determination of Dronedarone Hydrochloride and Its Potential Process-Related Impurities in Bulk Drug and Pharmaceutical Dosage Form. American Journal of Analytical Chemistry 2013; 4: 323-335.
17. Ahirrao VK, Patil CS, Bembalkar SR, Katariya MV, Sonnekar VS, MaratheRP, Nawale RB, Pawar RP. J. Chil. Stress degradation studies of dronedarone in pharmaceutical dosage form by a validated stability indicating LC method. Chem. Soc. 2012; 57(3): 1272-1276.
18. Kardile K, Damle MC, stability-indicating HPTLC method for quantitative estimation of Dronedarone hydrochloride in bulk and pharmaceutical dosage form. World journal of pharmacy and pharmaceutical sciences 2014; 3(6): 2163-2175.
19. Gupta SC, Kapoor VK, Fundamentals of mathematical statistics, 9th edition, S. Chand and Sons Educational Publishers, New Delhi, 1996, pp. 14.26.
Published
01-01-2015
Statistics
Abstract Display: 422 
PDF Downloads: 406
Dimension Badge
How to Cite
“STABILITY INDICATING UV SPECTROPHOTOMETRIC METHOD FOR DETERMINATION OF DRONEDARONE HYDROCHLORIDE”. International Journal of Pharmaceutical Sciences and Drug Research, vol. 7, no. 1, Jan. 2015, pp. 116-9, https://doi.org/10.25004/IJPSDR.2015.070121.
Issue
Section
Research Article
How to Cite
“STABILITY INDICATING UV SPECTROPHOTOMETRIC METHOD FOR DETERMINATION OF DRONEDARONE HYDROCHLORIDE”. International Journal of Pharmaceutical Sciences and Drug Research, vol. 7, no. 1, Jan. 2015, pp. 116-9, https://doi.org/10.25004/IJPSDR.2015.070121.
