A new, simple, accurate and economic reverse-phase HPLC method has been developed for quantification of Oxymetazoline Hydrochloride in nasal spray formulations. This developed method has been validated according to International Conference on Harmonization (ICH) guideline with respect to system suitability, specificity, precision, linearity, accuracy, and robustness. An isocratic condition of mobile phase Phosphate buffer (pH 3.0): Acetonitrile in a ratio of 60:40, v/v at a flow rate of 1.0 mL/minute over RP C18 (octadecylsilane (ODS), 250 × 4.6 mm, 5 µm, ECLIPSE X DB C-18) column at ambient temperature was maintained. This method is specific and showed excellent linear response with correlation coefficient (R2) values of 0.999, which was within the limit of correlation coefficient (R2 0.995). A simple and accurate reversed-phase HPLC method for the analysis of Oxymetazoline Hydrochloride in nasal spray formulations was developed and validated successfully.
A simple reverse-phase HPLC method for the estimation of Azelastine hydrochloride in nasal spray formulations has been developed. The method is simple, accurate, precise, specific and linear over the analysis range. This developed method has been validated according to International Conference on Harmonization (ICH) guideline with respect to system suitability, specificity, precision, linearity, accuracy, and robustness. An isocratic condition of mobile phase comprising Phosphate buffer (pH 3.1): Acetonitrile in a ratio of 60:40, v/v at a flow rate of 1.0 mL/minute over RP C18 (octadecylsilane (ODS), 250 × 4.6 mm, 5 µm, CHROMOSIL) column at ambient temperature was maintained. Besides, the chromatographic peak was observed sharp & symmetric. The proposed method was successfully applied for the estimation of the Azelastine hydrochloride in nasal spray formulation.
A new, simple, reliable and reproducible stability indicating RP-HPLC assay method has been developed for quantitative analysis of dexamethasone from dexamethasone tablets. This developed method has been validated according to ICH guideline with respect to system suitability, specificity, precision, linearity, accuracy and robustness. An isocratic condition of mobile phase water (0.1% orthophosphoric acid):acetonitrile in a ratio of 60:40, v/v at a flow rate of 1.0 mL/minute over RP 2.5 Fortis C18, 100 × 4.6 mm, 2.5 μm, column was at 27 ºC maintained. This method is specific and showed excellent linear response with correlation coefficient (R2) values of 0.999. In forced degradation, the proposed method has been investigated with different stress conditions as hydrolytic, oxidative, thermal and humid as recommended by ICH guidelines. An accurate and reliable reversed-phase HPLC method for the analysis of dexamethasone in dexamethasone tablets was developed and validated successfully.
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