A sensitive, rapid, precise, accurate high-performance liquid chromatographic method was developed for the estimation of Sorafenib (SOR) in the tablet dosage form. Chromatographic separation of SOR was carried out utilizing thermo-scientific model C18 column (4.6 mm i.d. X 250 mm; 5µm particle size) (based on 99.99 % ultra-high purity silica) using mobile phase that consisting of acetonitrile: methanol (40:60 v/v) at a flow rate of 1.0 mL/min. The absorption maximum (?max) of SOR in the mobile phase was found to be 265.5 nm. It had a retention time of 3.223 min. The calibration curve was in linear function of the drug in the concentration range of 2-10 µg/mL (r2 = 0.999) for the optimized method. The regression equation for SOR was found to be Y = 68228 x + 8071. The Detection Limit (DL) & Quantitation Limit (QL) results of SOR were found to be 0.526 µg/mL and 1.594 µg/mL respectively. The developed method was validated in pursuance of ICH Q2 (R1) guidelines. The method was linear, precise, accurate with recoveries in the range of 98 - 102 %, and minimum values of % RSD indicate the accuracy of the method. The detailed quantitative results of the study show that this method is precise, accurate, and cost-effective. Thus, the developed RP-HPLC method can be successfully feasible for the routine quality control analysis of SOR in a pharmaceutical dosage form.

Introduction:A simple, precise, and accurate HPLC method for simultaneous estimation of metformin hydrochloride (MET), pioglitazone hydrochloride (PIO), and glimepiride (GLIMP) was developed and validated.Materials and Methods:Chromatographic separation of the drugs was performed by using a Phenomenex-ODS-3 (C-18) column (250 × 4.60 mm, 5 μm) with a mobile phase consisting of methanol:acetonitrile:15 mM potassium dihydrogen phosphate (pH 4) in the proportion of 40:35:25 (v/v) at a flow rate of 1 ml/min. Detection was carried out using a UV-SPD-10AVP detector at 240 nm.Results:The retention time for MET, PIO, and GLIMP were 2.85 ± 0.03 min, 4.52 ± 0.03 min, and 7.08 ± 0.02min, respectively. Parameters such as linearity (0.2–50 μg/ ml for MET, 0.2–30 μg/ml for PIO, and GLIMP, respectively), precision (intra-day % RSD was 1.01–3.24 and inter-day % RSD was 1.54–4.09 for MET; intra-day % RSD was 1.03–2.09 and inter-day % RSD was 2.26–3.10 for PIO; and intra-day% RSD was 1.00–3.15 and inter-day % RSD was 1.58–3.07 for GLIMP), accuracy (99.66 ± 0.14 for MET, 98.46 ± 0.40 for PIO, and 98.62 ± 0.39 for GLIMP), specificity and robustness were calculated in accordance with ICH guidelines.Conclusions:The method was proved to be simple, rapid, precise, accurate, and cost effective.

A simple, sensitive, selective, accurate and economical spectrophoto-metric method have been described in the present work for the deter-mination of danazol in bulk drug and pharmaceutical formulations (tablets). Method is based on the formation of yellow coloured ion-association complexes between danazol and alizarine red S in acid medium followed by their extraction with chloroform, exhibiting absorption maxima at 430 nm, and obeying Beer′s law in the concen-tration range of 5-30 μg/mL. Statistical analysis of the results of the proposed methods reveals high accuracy and good precision. The proposed methods could be successfully extended to the commercial pharmaceutical formulations containing danazol.