Abstract
A stability-indicating reversed-phase high-performance liquid chromatography (HPLC) method with a high sensitivity was developed for the determination of silodosin (SIL) in the presence of hydrochlorothiazide (HCT) as an internal standard. Chromatographic separation of SIL and IS were successfully achieved on an Agilent ZORBAX CN column with an isocratic mobile phase composed of a mixture of methanol:acetonitrile:ammonium acetate (pH 4.0; 0.015 M) (40:30:30, v/v/v) at a flow rate of 1.3 mL min−1. The drugs were quantified using a photodiode array detector set at a wavelength of 270 nm. The reversed-phase HPLC method has been validated as per International Conference on Harmonisation (ICH) of Technical Requirements for Registration of Pharmaceuticals for Human Use guidelines to determine SIL in pharmaceutical dosage form. The proposed method showed a good linearity in the concentration range of 4.0–600.0 μM with a lower detection limit of 85.0 nM under optimized conditions. The statistical performance of the fully validated HPLC method was compared to our developed sensitive spectrofluorimetric method, and the performance results of the proposed HPLC method were considerably satisfactory. The validated method was successfully applied to quantify the SIL in capsules, and the corresponding recovery value was found to be 99.5 %. The validated HPLC method may be a promising alternative analytical tool for routine analysis of SIL in pharmaceutical samples.
Highlights
A stability-indicating reversed-phase high-performance liquid chromatography (HPLC) method with a high sensitivity was developed for the determination of silodosin (SIL) in the presence of hydrochlorothiazide (HCT) as an internal standard
The literature revealed that various analytical methods have been reported to determine the SIL in pharmaceutical or clinical samples including UV spectrophotometry (Jahan and Malipatil 2014b), spectrofluorimetry (Bhamre and Rajput 2014), high-performance liquid chromatography (HPLC) (Jahan and Malipatil 2014a ; Aneesh and Rajasekaran 2012; Vali et al 2012), high-performance thin-layer chromatography (Sayana et al 2012), ultra high-performance liquid chromatography (UHPLC) (Shaik et al 2014; Prasad et al 2012) and liquid chromatographytandem mass spectrometry (LC-MS/MS) (Zhao et al 2009) and electrochemicalsensing (Er et al 2015) methods
The present study has indicated accurate and efficient analytical methods based on reversed-phase HPLC and spectrofluorimetry for the determination of SIL in a pharmaceutical sample
Summary
A stability-indicating reversed-phase high-performance liquid chromatography (HPLC) method with a high sensitivity was developed for the determination of silodosin (SIL) in the presence of hydrochlorothiazide (HCT) as an internal standard. BPH is a common disorder of the urogenital tract for at least 50 % of men aged over 50 years (Goi et al 2015). At this point, SIL has been proven to advanced relieve the muscles in the prostate by reducing lower urinary tract symptoms related to BPH (Goi et al 2015; Yoshida et al 2007). The authors have attached great importance develop the sensitive and reliable analytical methods for. All solutions and mobile phase were prepared with ultrapure water using Waters Milli-Q Plus purification system
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