Development & validation of stability indicating HPLC method for determination of Solifenacin in bulk formulations

International Journal of Pharmacy and Pharmaceutical Sciences

Volumn 3, Issue 1, 2011, Pages 70-74

  Desai, Nilesh ^a   Hussen, Syed Sajjad ^a   Vasanthraju, S G ^a   Karthik, A ^a   Udupa, N ^a  

^a MANIPAL COLLEGE OF PHARMACEUTICAL SCIENCES   (India)

Author keywords

HPLC; Photo diode array detector; Solifenacin; Stability indicating

Indexed keywords

ACETONITRILE; POTASSIUM DIHYDROGEN PHOSPHATE; SOLIFENACIN; WATER;

ACCURACY; ARTICLE; DEGRADATION; DIODE; DRUG DETERMINATION; DRUG FORMULATION; DRUG STABILITY; FLOW RATE; HEAT; HIGH PERFORMANCE LIQUID CHROMATOGRAPHY; HUMAN; HYDROLYSIS; OXIDATION; PH; QUANTITATIVE ANALYSIS; SENSITIVITY AND SPECIFICITY; VALIDATION PROCESS;

EID: 79251592239     PISSN: 09751491     EISSN: 09751491     Source Type: Journal    
DOI: None     Document Type: Article

References (9)

1. Product monograph, Astellas Pharma Canada, Inc [cited, July 24, 2008]. Available from: http://www.astellas.com/ca/media/pdf/Vesicare_Product_Monograph.pdf
2. Ohtake A, Ukai M, Hatanaka T, Kobayashi S, Ikeda k, Sato S et al. In vitro and in vivo tissue selectivity profile of Solifenacin succinate (YM905) for urinary bladder over salivary gland in rats. European Journal of Pharmacology 2004; 492: 243-250.
3. Ito Y, Oyunzul L, Yoshida A, Fujino T, Noguchi Y, Yuyama H et al. Comparison of muscarinic receptor selectivity of solifenacin and oxybutynin in the bladder and submandibular gland of muscarinic receptor knockout mice. European Journal of Pharmacology 2009; 615:201-206.
4. Suzuki M, Ohtake A, Yoshino T, Yuyama H, Hayashi A, Ukai M et al. Effects of solifenacin succinate (YM905) on detrusor overactivity in conscious cerebral infarcted rats. European Journal of Pharmacology 2005; 512: 61-66.
5. Hiren N, Arvind G, Pudage A, Dhiraj M, Pranav S. Highly sensitive and rapid LC-ESI-MS/MS method for the simultaneous quantification of uroselective α1-blocker, alfuzosin and an antimuscarinic agent, solifenacin in human plasma. J. Chromatogr. B 2008; 876: 236-244.
6. Yanagihara T, Aoki T, Soeishi Y, Iwatsubo T, Kamimura H. Determination of solifenacin succinate, a novel muscarinic receptor antagonist, and its major metabolite in rat plasma by semi-micro high performance liquid chromatography. J. Chromatogr. B 2007; 859: 241-245.
7. ICH Q2 (R1) Validation of Analytical Procedures, Text and Methodology, 2005.
8. ICH Q1A (R2), Stability Testing of New Drug Substances and Products, International Conference on Harmonisation, 2003.
9. Bakshi M, Singh S, Development of validated stabilityindicating assay methods-critical review. J. Pharm. Biomed. Anal. 2002; 28: 1011-1040.