Abstract
A new, accurate, precise, and robust HPLC method was developed and validated for the determination of solifenacin in tablet dosage form. The chromatographic separation was achieved on an Inertsil ODS 3V C18 (150 mm × 4.6 mm, 5 μm) stationary phase maintained at ambient temperature with a mobile phase combination of monobasic potassium phosphate (pH 3.5) containing 0.1% triethylamine and methanol (gradient mode) at a flow rate of 1.5 mL/min, and the detection was carried out by using UV detector at 220 nm. The performance of the method was validated according to the present ICH guidelines.
Highlights
Solifenacin succinate is a competitive muscarinic acetylcholine receptor antagonist used in the treatment of overactive bladder with or without urge incontinence
The main goal of the present study is to develop and validate the novel simple, higher sensitive, selective, rugged, and reproducible analytical method for quantitative determination of solifenacin in pharmaceutical compounds by HPLC
Several HPLC methods were developed for the estimation of solifenacin using methanol, water, acetonitrile and phosphate, acetate, and OPA buffer
Summary
Solifenacin succinate is a competitive muscarinic acetylcholine receptor antagonist used in the treatment of overactive bladder with or without urge incontinence. After oral administration of vesicare to healthy volunteers, peak plasma levels (Cmax) of solifenacin are reached within 3 to 8 hours after administration and at steady state ranged from 32.3 to 62.9 ng/mL for the 5 and 10 mg vesicare tablets, respectively. Solifenacin is approximately 98% (in vivo) bound to human plasma proteins, principally to alpha-1-acid glycoprotein [1,2,3,4,5,6,7,8,9,10]
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