Objective: The objective of this research was to develop a simple, precise, accurate, and stability-indicating reverse-phase high-performance liquid chromatographic method for estimation of azelastine hydrochloride (AZL) in nasal spray preparation. Methods:Chromatography was performed on a 250 mm×4.6 mm, 5-μm particle size, Waters Spherisorb CN column using (50:50 v/v) mixture of potassium dihydrogen phosphate buffer and acetonitrile as mobile phase. The detection was carried out at 290 nm and flow rate employed was 1.0 ml/min. The degradation of AZL was studied under different ICH recommended stress conditions. Results:The retention time was 4.34 min for AZL. Linearity was established in the concentration range of 5-120 µg/ml, with a correlation coefficient of 0.9996. Limit of detection (LOD) and limit of quantitation (LOQ) were found to be 0.81 µg/ml and 2.44 µg/ml, respectively. Percentage recovery was found between 99 and 102%. The values of percentage relative standard deviation (<2%) proved the high precision of the proposed method. The method was found to be robust regarding any small variation in the column temperature, pH of mobile phase, and mobile phase ratio. AZL was found stable in 5 M HCl at 80°C for 5 h, 5 M NaOH at 80°C for 5 h, 30% H 2 O 2 at 80°C for 5 h, and in oven at 70°C for 8 h. Conclusion:The results obtained in this research work clearly proved that the proposed HPLC method for the assay of AZL in nasal spray preparation is simple, precise, specific, accurate, and stability indicating. It indicates that the method is suitable for analysis of AZL in the raw material and the pharmaceutical product without interference from excipients.
A simple, sensitive, specific, accurate, and stability-indicating reversed phase high performance liquid chromatographic method was developed for the simultaneous determination of aspirin and prasugrel, using a Kromasil 100 C18 (150×4.6 mm, 5 μ) column and a mobile phase composed of acetonitrile:methanol:water (30:10:60, v/v), pH 3.0 adjusted with o-phosphoric acid. The retention times of aspirin and prasugrel were found to be 3.28 min and 6.61 min, respectively. Linearity was established for aspirin and prasugrel in the range of 15-150 and 2-20 μg/ml, respectively. The percentage recoveries of aspirin and prasugrel were found to be in the range of 99.34-100.32% and 98.92-102.09%, respectively. Both the drugs were subjected to acid, alkali and neutral hydrolysis, oxidation, dry heat, and UV degradation. The degradation studies indicated aspirin to be more susceptible to alkaline hydrolysis, while prasugrel to be more susceptible to neutral hydrolysis. The degradation products were well resolved from the pure drug with significant differences in their retention time values. This method can be successfully employed for simultaneous quantitative analysis of aspirin and prasugrel in bulk drugs and formulations.
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