[Invitro comparison studying of dissolution profiles for pharmacopoeial and nonpharmacopoeial native anticonvulsants oral solid dosage forms with brand name]

Dissolution is very important parameter in releasing of active pharmaceutical ingredient from dosage form, and this directly correlate with absorption process and consequently with bioavailability of oral dosage forms [tablet]. Oxcarbazepine is an oral anticonvulsant, and in this research we work on Invitro comparison of dissolution protiles for two native oxcarbazepine tablet 300 mg products with the same of patented [trileptal[rigstered]], calculating similarity factor f[2] as the base of comparison, the value of similarity factors were for product-A [f[2]=77.1], for product-B [f[2]=51] appear similarity of dissolution profiles of two previous product with the same of patented

[Stability study of ezetimibe in raw material and tablets]

Stress conditions were applied on the tested drug [Ezetimibe] according to ICH guidelines. Degradation was found to occur in basic conditions and to much less extent in acidic conditions. The tested compound was stable in light and thermal stress conditions. The analytical validated RP-HPLC method, which has been developed for assaying Ezetimibe previously, is used as stability indicating method. The assay was performed using a C18 column and a mobile phase consist of 50% Acetonitril and 50% buffer [10mm potassium phosphate, pH=2.5 adjusted using phosphoric acid]. The flow rate was 1 ml/min and the analyte was determined using a UV detector at 240 nm. The developed analytical procedure was able to separate the drug from its degradation products, and it was a stability indicating method. Several batches of local manufactured Ezetimibe tablets with different manufacturing dates were assayed. No degradation products were observed in all tested samples, which indicates the stability of Ezetimibe tables in the current conserving conditions

Development and validation of RP-HPLC method for determination of ezetimib in raw material and tablets

The effective 2-azetidione cholesterol absorption inhibitor Ezetimibe is widely used in the treatment of Hyperlipidemia. A specific sensitive and rapid RP-HPLC method has been developed for assaying ezetimibe in raw material and in tablets. The assay was performed using a CIS column and a mobile phase consist of 50% Acetonitril and 50% buffer [10mm potassium phosphate, pH=2.5 adjusted using phosphoric acid]. The flow rat was 1 ml/ min and the analyze was determine using a UV detector at 240 nm. The assay method optimized and the best method was validated, all validation parameters were within the acceptance range