The purpose of the present study was to prepare inclusion complex of domperidone with hydroxylpropyl-β-cyclodextrin in order improved the solubility and hence to increase dissolution of domperidone. An effect of concentration of hydroxylpropyl-β-cyclodextrin on the aqueous solubility of domperidone was determined by phase-solubility method. The aqueous solubility of domperidone increased as a function of hydroxylpropyl-β-cyclodextrin concentration, showing AL type diagram. Solid domperidone/hydroxylpropyl-β-cyclodextrin complex was prepared in ratio 1:1 by ultrasonication and kneading method. Solid state inclusion complex was characterized by FTIR, powder X-ray diffraction and differential-scanning calorimetry techniques. FTIR studies showed intactness of drug in complex whereas powder diffraction studies showed that hydroxylpropyl-β-cyclodextrin complex was amorphous. Solubility studies showed that complexation increased domperidone solubility as compared to pure drug in 0.1M hydrochloric acid and distilled water. Drug content confirms that ultrasonication is one of the efficient methods to prepare inclusion complex. Dissolution data of inclusion complexes also indicated that there is 1.4 folds increase in dissolution as compared to pure drug and was observed in case of inclusion complexes prepared by ultrasonication.
Objective: The present study was undertaken to develop a rapid, simple, specific and economic ultraviolet (UV) spectrophotometric method for estimating the Salbutamol Sulphate (SS) in pharmaceutical formulations. Methods:The analysis was performed at λ max 276 nm using Sorenson's isotonic phosphate buffer pH 7 (SIPB pH 7) as blank/diluent. The method was validated by following the analytical performance parameters as suggested by International Conference on Harmonization (ICH) which included accuracy, precision, linearity. Results:The drug follows the beer's lambert's law in the concentration range of 12.5-37.5μg/ml and exhibited good correlation coefficient (0.9997) and excellent mean recovery. Percentage RSD for precision and accuracy of the method was found to be less than 2%. This method was successfully applied for the determination of the Salbutamol Sulphate in commercial brands of Indian market and the results were in good agreement with the label claims. The developed method was suitable and specific to the analysis of Salbutamol Sulphate even in the presence of common excipients. Conclusion:The obtained results proved that the validated method can be employed for the routine analysis of Salbutamol Sulphate in bulk as well as in the commercial formulations.
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