For the quantification of ebastine in pharmaceutical suspension, a simple, quick, accurate, and exact stability-indicating HPLC approach was developed and validated. The drug was determined using a phase reverse system and the separation was performed in an analytical C18 column (250 mm x 4.6 mm, 5 μm). The mobile phase consists of 0.1% orthophosphoric acid and methanol in a 25:75, v/v ratio. Using a concentration range of 10–90 μg mL-1, the technique demonstrated a strong linear response (r=0.999). Effluents were measured at 262 nm while the flow rate was kept at 1.0 mL min-1. There was a retention time of 3.506 min. The method was statistically validated to determine its accuracy, precision, linearity, ruggedness, robustness, solution stability, selectivity, and forced degradation assessments. The stresses that were used were acid, alkali hydrolysis, water stress, oxidation, photolysis, and heat. Since the degradation products did not affect the capacity to identify ebastine, this technique may be taken as a stability indication. This methodology may be utilized for the analysis of Ebastine in pharmaceutical suspension, since the findings obtained were within the limits set by ICH standards.
A rapid, accurate, and precise HPLC approach for quantifying calcium orotate in capsule dosage form was developed and validated. As optimum conditions for analysis, a C8 column (250 mm x 4.6 mm, 5μ) was used as the stationary phase, with a mobile phase of 65:35 v/v acetonitrile and 25 mM potassium dihydrogen phosphate buffer (pH 4.7) at a flow rate 1 ml/min and detected at 254 nm. The method showed a 0.999 correlation and an excellent linear response throughout a concentration range of 15-90 μg/ml. Retention lasted for 3.186 minutes. Validation of the method done as per the requiremnts of ICH and subjected to oxidation, photolysis, heat, acid, alkali hydrolysis, and water stress. Degradation byproducts did not affect the ability to detect calcium orotate, hence the approach is stability indicating. The approach may be used to determine calcium orotate in pharmaceutical capsule dose form since the findings of the research were within the parameters of ICH standards.
scite is a Brooklyn-based organization that helps researchers better discover and understand research articles through Smart Citations–citations that display the context of the citation and describe whether the article provides supporting or contrasting evidence. scite is used by students and researchers from around the world and is funded in part by the National Science Foundation and the National Institute on Drug Abuse of the National Institutes of Health.