ANDA Dissolution Method Development and Validation

the development and validation of dissolution method for donepezil tablet

Discriminatory Dissolution Method Development and Validation for Cephalexin Od Tablets

In this study, a discriminative dissolution method was developed for Cephalexin OD (orally disintegrating) tablets 750mg. The solubility and stability of the cephalexin API was determined in ten different solutions. In that 0.01N HCl, glycine buffer pH 3-0, acetate buffer pH 4.5 and water gave good stability and the solubility. Dissolution profiling of cephalexin OD tablets 750mg of single batc...

Development and Validation of a RP-HPLC Method for the Quantitation and Dissolution Studies of Valdecoxib

An isocratic high-performance liquid chromatography (HPLC) procedure was developed for the dissolution rate studies and quantitative determination of valdecoxib in solid dosage forms and in active pharmaceutical ingredient. HPLC separation was carried out by reversed phase chromatography on a Synergi® fusion C18 column (150 mm x 4.6 mm i.d.; 4 μm particle size), held at 30 oC. The mobile phase ...

Development and validation of dissolution method for levocetirizine dihydrochloride by isocratic reverse phase HPLC

Levocetirizine hydrochloride is an orally active, non-sedative antihistamine used in the symptomatic relief of seasonal and perennial allergic rhinitis. The main objective of the proposed study is to develop and validate a dissolution method of Levocetirizine hydrochloride dosage form by reverse phase HPLC isocratic method. The method is optimized by various filteration methods such as centrifu...

Development and validation of a selective online dissolution method for rosiglitazone maleate.

A new specific, accurate, precise, and reproducible selective online dissolution method for rosiglitazone maleate is developed and validated for the dissolution of rosiglitazone maleate in pharmaceutical formulations. The rationale of the method is based on the direct measurement of the absorbance of the analyte in the buffer medium at 242 nm using buffer as blank. Dissolution is achieved on a ...