A Validated Rapid Stability-Indicating Method for the Determination of Related Substances in Solifenacin Succinate by Ultra-Fast Liquid Chromatography

Abstract

A rapid, sensitive, and accurate ultra-fast liquid chromatographic method is developed for the determination of related substances and degradants of Solifenacin Succinate, an active pharmaceutical ingredient used in the treatment of overactive bladder. Chromatographic separation of Solifenacin Succinate, its related substances, and degradants was achieved using a Shimpack XR-ODS-II column and mobile phase system containing 10 mM potassium dihydrogen orthophosphate in water. The pH of the buffer was adjusted to 7.0 using triethyl amine (mobile phase A). LC-grade acetonitrile was used as mobile phase B, employing a binary-gradient program at a flow rate 0.5 mL/min. The resolution between the critical pair of peaks (Impurity A and analyte) was found to be greater than 3.5. The limits of detection and quantification (LOQ) of Impurity A, Impurity B, and the analyte were 0.2 and 0.6 μg/mL, respectively for a 5-μL injection volume. The percentage recovery of impurities in the presence of sample matrix ranged from 95 to 104 w/w. The test solution and mobile phase was observed to be stable up to 24 h after the preparation. The validated method yielded good results of precision, linearity, accuracy, robustness, and ruggedness. The proposed method is found to be rapid, accurate, and suitable for the quantitative determination of related substances and degradants during quality control of Solifenacin Succinate active pharmaceutical ingredient.

Development and validation of stability-indicating HPLC method for solifenacin succinate: Isolation and identification of major base degradation product

“…Two liquid chromatography-mass spectrometry (LC-MS) methods are reported to quantify SLN in plasma [7,8] and recently one article related to development of stability-indicating method for the determination of related substances in solifenacin succinate by ultra-fast liquid chromatographic method has been published [9]. The International Conference on Harmonization (ICH) guideline entitled "Stability testing of New Drug Substances and Products" requires that stress testing be carried out to elucidate the inherent stability characteristics of the active substance [10].…”

Analytical Method Development and Validation of Solifenacin in Pharmaceutical Dosage Forms by RP-HPLC

“…Literature survey reveals that quantification of solifenacin in human plasma [11,12], rat plasma [13], pharmaceutical compounds [14][15][16][17], and industrial waste streams [18] was reported. These methods were reported by using LC-MS/MS [11,12,18], HPLC [13][14][15][16], and HPTLC [17]. Among all, quantification of solifenacin by LC-MS/MS in biological matrices [11][12][13] was proved best results.…”

“…The reported HPLC methods [13][14][15][16] have some drawbacks in terms of ruggedness, reproducibility, and sensitivity in long run. 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.…”

Bioanalytical method for quantification of Solifenacin in rat plasma by LC-MS/MS and its application to pharmacokinetic study

“…Literature survey reveals that quantification of Solifenacin in human plasma (Macek et al 2010;Mistri et al 2008), rat plasma (Yanagihara et al 2007), pharmaceutical compounds (Krishna et al 2010;Desai et al 2012;Rami Reddy et al 2013;Desai et al 2011), and industrial waste streams (Ann-Marie et al 2011) were reported. These methods were reported by using liquid chromatographyelectrospray ionization-tandem mass spectrometry (LC-MS/ MS) (Macek et al 2010;Mistri et al 2008;Ann-Marie et al 2011), high-performance liquid chromatography (HPLC) (Yanagihara et al 2007;Krishna et al 2010;Desai et al 2012;Rami Reddy et al 2013), and HPTLC (Desai et al 2011).…”

“…These methods were reported by using liquid chromatographyelectrospray ionization-tandem mass spectrometry (LC-MS/ MS) (Macek et al 2010;Mistri et al 2008;Ann-Marie et al 2011), high-performance liquid chromatography (HPLC) (Yanagihara et al 2007;Krishna et al 2010;Desai et al 2012;Rami Reddy et al 2013), and HPTLC (Desai et al 2011). Among all, quantification of Solifenacin by LC-MS/MS in biological matrices (Macek et al 2010;Mistri et al 2008;Yanagihara et al 2007) was proved best results.…”