Objective: The aim of this study was to formulate and optimize solid lipid nanoparticles (SLNs) for the enhancement of solubility and bioavailability of the poorly aqueous soluble drug rosuvastatin calcium.Methods: SLNs were prepared by slight modification of solvent emulsification-diffusion technique and analyzed for particle size, zeta potential, drug entrapment efficiency, in vitro drug release, stability, and pharmacokinetic studies. Rosuvastatin calcium SLNs were formulated using stearic acid as main lipid, poloxamer 407 as surfactant, and Tween 80 as cosurfactant.Results: All parameters were found to be in an acceptable range. Optimized formulation OR2 SLNs have shown mean particle size 115.49±2.97 nm with polydispersity index value of 0.456, zeta potential - 18.40 mV, 60.34% drug loading, and 97.16% drug entrapment efficiency. In vitro drug release was found to be 88.70±3.59% after 12 h with sustained release and was fitted with Higuchi model with a very high correlation coefficient (R2=0.9905). Transmission electron microscopy confirms that the SLNs of selected optimized formulation are circular in shape. Differential scanning calorimetry and X-ray diffraction confirm the formation of amorphous product. 1H nuclear magnetic resonance studies confirm the intermolecular hydrogen bonding between drug and lipid. Pharmacokinetic studies showed an optimized formulation OR2 SLNs enhanced bioavailability with 4.44-fold as compare to plain drug suspension. Optimized formulation OR2 SLNs have shown good stability at 25±2°C and 60±5°C relative humidity for 180 days.Conclusion: Thus, the current study can be useful for the successful development of optimized SLNs and able to enhance the bioavailability of poorly soluble drug rosuvastatin calcium.
Objective: The aim of the present work was to develop a simple and sensitive UV spectrophotometric method for the estimation of rosuvastatin calcium in bulk and in pharmaceutical dosage form.Rosuvastatin Material and methods: calcium exhibits maximum absorbance at 244 nm with apparent molar absorptivity of 7.1862 × 10 L/mol.cm in 4 methanol as solvent. Beer's law was found to be obeyed in the concentration range 2-18 µg /ml for rosuvastatin calcium. Result and discussion: The results of the study demonstrated that the developed procedure was accurate, precise and economical. This method is further extended to pharmaceutical dosage form.In this method, no Conclusion: interference from any pharmaceutical additives and diluents were found. The validation of the analysis was done by statistically and recovery studies.
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