World Journal of
Pharmaceutical and Life Sciences

A VALIDATED BIOANALYTICAL METHOD FOR QUANTIFICATION OF SOLIFENACIN BY LC-MS AND ITS APPLICATION TO A PHARMACOKINETIC STUDY

Srinivasa Rao Polagani and Venkateswarlu Gandu*

ABSTRACT

A simple, high throughput, direct-injection high-performance liquid chromatography tandem mass spectrometry method (LC/MS/MS) has been developed and validated for the quantitation of Solifenacin in human plasma using Solifenacin D5 as internal standard (IS). Analyte and the IS were extracted from the 100 ?L of K2 EDTA human plasma by simple Solid Phase extraction. The on-line extraction was achieved on a Strata-X 33?m polymeric sorbent cartridge (30 mg/1 mL). The extracted analyte was eluted by a mobile phase which contained 5mM ammonium acetate buffer in 0.1% formic acid and methanol (20:80% v/v). The analytical column was a Zorbax SB C18 column (4.6mm×50 mm, 3.5 ?m). The standard curve, which ranged from 0.20 to 30.1ng/ml, was fitted by a weighted (1/x2) quadratic regression model. The Mass detection of Solifenacin involves m/z - 363.20 (parent) and 110.00 (product) and Solifenacin D5 involves m/z - 368.20 (parent) and 110.00 (product) as internal standard in Positive ion mode.Method validation was performed as per FDA guidelines and the results met the acceptance criteria. The intra-day and inter-day precision (%CV) and accuracy results in six validation batches across six concentration levels were well within the acceptance limits. A run time of 1.60 min for each sample made it possible to analyze more number of samples in short time, thus increasing the productivity. The proposed method successfully applied to a pharmacokinetic study of Solifenacin 10 mg tablet in healthy, adult, human male subjects under fed condition.

[Full Text Article]   [Download Certificate]