A reliable and sensitive isocratic stability indicating RP-UPLC method has been developed and validated for quantitative analysis and content uniformity study of levofloxacin hemihydrate in tablets. An isocratic method for analysis of levofloxacin hemihydrate was archived on ACQUITY UPLC BEH C18 (100*2.1) mm particle size 1.7 μ columns within shorter runtime of 4 min with a flow rate of 0.400 mL/min and using a photodiode array detector to monitor the eluate at 294 nm. The mobile phase consisted of acetonitrile-buffer (23 : 77 v/v), (buffer: 20 mM K2HPO4 + 1 mL triethylamine in 1 L water, pH=2.50 by orthophosphoric acid). Response was a liner function of drug concentration in the range of 0.5–80 μg/mL (r2=0.999) with a limit of detection and quantification of 0.1 and 0.5 μg/mL, respectively. Accuracy (recovery) was between 99.77% and 101.55%. The drug was subjected to oxidation, hydrolysis, photolysis, and thermal degradation. Degradation products resulting from the stress studies did not interfere with the detection of levofloxacin hemihydrate, and the assay is stability indicating.

A simple, precise, and accurate HPLC method has been developed and validated for the quantitative analysis of Dronedarone Hydrochloride in tablet form. An isocratic separation was achieved using a Waters Symmetry C8 (100 × 4.6 mm), 5 μm particle size column with a flow rate of 1 ml/min and UV detector at 290 nm. The mobile phase consisted of buffer: methanol (40:60 v/v) (buffer: 50 mM KH2PO4 + 1 ml triethylamine in 1 liter water, pH=2.5 adjusted with ortho-phosphoric acid). The method was validated for specificity, linearity, precision, accuracy, robustness, and solution stability. The specificity of the method was determined by assessing interference from the placebo and by stress testing the drug (forced degradation). The method was linear over the concentration range 20–80 μg/ml (r2 = 0.999) with a Limit of Detection (LOD) and Limit of Quantitation (LOQ) of 0.1 and 0.3 μg/ml respectively. The accuracy of the method was between 99.2–100.5%. The method was found to be robust and suitable for the quantitative analysis of Dronedarone Hydrochloride in a tablet formulation. Degradation products resulting from the stress studies did not interfere with the detection of Dronedarone Hydrochloride so the assay is thus stability-indicating.

The simplest stability indicating reversed phase Isocratic HPLC and UPLC methods has been developed and validated for the determination of fluconazole in bulk and solid pharmaceutical dosage form. A SunFire C18 (250 × 4.5 mm, 5 μm particle size) column has been used for HPLC and BEH C18 (100 × 2.1 mm, 1.7 μm particle size) column used for UPLC. The Mobile phase consisted of Methanol : Water (70 : 30) for HPLC and Methanol : Water (55 : 45 v/v) for UPLC. Isocratic flow was set at 1 mL/min and 0.30 mL/min, respectively, for HPLC and UPLC. For both HPLC and UPLC system detection has been performed at 211 nm with 30°C column oven temperature (good elution was obtained at 30°C) and injection volume, respectively, 2 μL and 20 μL for HPLC and UPLC.

A reverse phase high performance liquid chromatography (HPLC) method has been developed for the separation of two geometric isomers of Acrivastine using crude reaction mixture. The resolution between two isomers was found more than 2.9. The geometric isomers have been isolated by preparative HPLC and characterized by spectroscopic techniques, such as NMR, infrared, and MS. The developed method has been validated for the determination of Z-isomer in Acrivastine. The limit of detection and limit of quantification of the Z-isomer were 0.05 and 0.2 μg/ml, respectively. The developed method is precise, linear, accurate, rugged and robust for its intended use.

A simple, precise, rapid reproducible, selective, and stability indicating reverse phase UPLC method has been developed for the estimation of dronedarone in pharmaceutical dosage form. Estimation of dronedarone hydrochloride was achieved on Acquity BEH C 18 (100 mm * 2.1 mm) 1.7 m column using buffer [20 mM KH 2 PO 4 + 1 mL Triethylamine (pH = 2.5 by orthophosphoric acid)] and methanol in ratio of 40 : 60 as mobile phase at 30 ∘ C. The flow rate was 0.4 mL/min and effluents were monitored at 290 nm. The method was validated with respect to linearity, accuracy, precision, LOD, LOQ, and robustness. The method was linear over the concentration range 0.38-90 g/mL ( 2 = 0.999), with a limit of detection and quantification of 0.1 and 0.38 g/mL, respectively. Dronedarone was subjected to acid and alkali hydrolysis, chemical oxidation, dry heat degradation, and photo (sunlight) degradation. The degraded product peaks were well resolved from the drug peak with significant difference in their retention time value.