Mobile phase

This research introduces a straightforward, rapid, sensitive, and selective analytical method for measuring daprodustat in both bulk powder and tablet forms. The techniques used include UV-Visible spectrophotometry and reversed-phase high-performance liquid chromatography (RP-HPLC). For the UV-Visible method, a Systonic AU-2702 double-beam spectrophotometer was used to measure Daprodustat 's absorbance at 265 nm. The RP-HPLC procedure employed a Shimadzu SPD-10A C18 column (250×4.6 mm, 5 µm). The mobile phase consisted of a mixture of acetonitrile and distilled water (70:30, v/v), with 0.1% formic acid added. Key operational parameters included a flow rate of 1.2 mL/min, an injection volume of 10 μL, and a column temperature of 30 °C. The method's linearity ranged from 10 to 100 μg/mL. The entire procedure was validated following ICH Q2 (R1) guidelines, confirming its specificity, linearity, sensitivity, precision, accuracy, robustness, and system suitability. The technique yields highly sensitive results, with Limits of Detection (LODs) and Limit of Quantification (LOQs) of 0.6174 μg/mL and 1.87μg/mL for daprodustat. Recovery rates ranged from 98% to 102%, and both intra-day and inter-day precision (measured by % RSD) were below 2%. The method demonstrated excellent specificity, avoiding interference from excipients or formulation matrices. Overall, this study provides a complete analytical framework applicable for routine pharmaceutical analysis, ensuring quality control, safety assessment, and regulatory compliance for daprodustat.   

The article, for the first time, reports High performance liquid chromatography [HPLC] method for estimation of Dapoxetine hydrochloride [DAP] and Tadalafil hydrochloride [TAD]. The analytical method was developed for both the drugs as API and for tablet dosage form. The separation of two drugs was achieved on High quality octa decyl silane [C18 250x 4mm i.d] 5μ column. The mobile phase consists of Acetonitrile and phosphate buffer in the ratio of 45:55. Mobile phase flow rate adjusted at 1 ml/min and pH at 4.2 using ortho phosphoric acid. The detection was carried out at a wavelength 254 nm. Retention time was found 4.46 and 10.11 min respectively for TAD and DAP. The method was validated for system suitability, linearity, accuracy, and precision and solution stability as per ICH guidelines. Linearity was obeyed in the range of 8-48 mg/ml and 24- 144 mg/ml with correlation coefficient of 0.997 and 0.998 for TAD and DAP respectively. Recovery studies were found within prescribed limits that was 98.83 for TAD and 98.93 for DAP respectively. Detection and quantification limit were found to be 0.225mg/ml and 0.682mg/ml for TAD and 0.163 mg/ml and 0.494mg/ml for DAP respectively which expresses higher sensitivity of the method. Assay results were found to be 98.52 % and 98.26 % in generic brand whereas 99.03 % and 98.11 in other brand for TAD and DAP respectively.