RP-HPLC METHOD FOR THE ESTIMATION OF TAMSULOSIN AND SOLIFENACIN IN BULK AND ITS DOSAGE FORMSAbstract
A liquid chromatographic method has been developed and validated for the determination of the clinical trial combination of Solifenacin succinate and Tamsulosin hydrochloride. Effective chromatographic separation was achieved on an eclipse XDB-C18 (4.6 mm X 150 mm, 5µm) column using isocratic reverse phase technique. The mobile phase employed was ACN: 20Mm sodium phosphate buffer (0.2% Triethylamine) (30:70), the pH was adjusted to 3.0 by ortho phosphoric acid. The flow rate was maintained at 1.0 mL/min and elutewasmonitoredat225nm. A linear response was observed over the concentration range 15-75 µg/mL (R2=0.999) of Solifenacin and the concentration range 1-5 µg/mL (R2=0.999) of Tamsulosin.The limit of quantitation (LOQ) and limit of detection (LOD) for Solifenacin were 0.04 and 0.14 µg/mL, respectively and for Tamsulosin were 0.05 and 0.1 µg/mL, respectively. The method was successfully validated in accordance to ICH guideline Q2. The RSD for intra-day and for inter-day precision were found to be lesser than 1.5% for Solifenacin. The RSD for intra-day and for inter-day precision were found to be lesser than 1% for Tamsulosin. The percentage recovery was found to be greater than 98.0 %.The method was found to be accurate, precise, linear, specific, sensitive, rugged, robust and stability indicating.
D. Samson Israel*, K. Krishnachaitanya, D. GowriSankar
University College of Pharmaceutical Sciences, Andhra University, Visakhapatnam-530003, Andhra Pradesh, India
19 June, 2013
16 July, 2013
25 October, 2013
01 November, 2013