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.

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Objective: To develop and validate a novel and simple reverse phase Ultra Performance Liquid Chromatography (UPLC) method for simultaneous determination of Fluticasone Propionate and Salmeterol Xinafoate from pharmaceutical finished product, applying Quality by design (QbD) approach. Methods: The proposed analytical method developed and validated in a linear gradient condition at a flow rate of 0.40 ml/min over Waters ACQUITY BEH Shield RP 18, 2.1*100 mm, 1.7 µm column by maintaining column oven temperature at 30 °C and Sample cooler temperature at 15 °C. Chromatograms monitored and recorded at 215 nm. Results: The proposed method has been validated as per International Conference on Harmonization (ICH) guidelines with respect to system suitability, specificity, precision, linearity, accuracy, range, solution stability and robustness. This method is qualified in all parameters in case of system suitability and specificity; precision observed within the limit of 2.0%, the excellent linear response observed with correlation coefficient (R2) for Salmeterol 0.99999 and Fluticasone Propionate 0.99999, for Accuracy within the limit of 98% to 102%. Conclusion: A selective, suitable and accurate reverse phase UPLC method for simultaneous Determination of Fluticasone Propionate and Salmeterol Xinafoate in the pharmaceutical finished product has been developed and validated successfully.

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.