DETERMINATION AND EVALUATION OF PRAZOSIN HYDROCHLORIDE SUSTAINED RELEASE TABLETS AT DIFFERENT PH BY RP-HPLC METHOD

Komathi A., Bakyalakshmi M.*, Gokulan P. D. and Senthilkumar K. L.

ABSTRACT

The aim of this study was to provide comparative evaluation of multimedia dissolution profile studies conducted for the “Prazosin SR Tablets 5 mg” Generic and Branded Product. Generic drugs are equivalent to the Branded products if they have same active substance, the same pharmaceutical form, the same Therapeutic Indications and a similar Bioequivalence with respect to the Reference Medical product. A simple, sensitive and accurate In-vitro dissolution method was used according to USP dissolution testing methodologies with different media’s to ensure that manufactured generic product maintains its drug release as per the reference lead drug product by using RP-HPLC method. The In-vitro dissolution profile was obtained using 900ml of four different media like 0.1N Hcl, Acetate Buffer 4.5, Phosphate Buffer 6.8 and 0.1N Hcl with 2% of SLS as Dissolution Medium at 37ºC ± 0.5ºC and USP I (Basket) with 100 rpm. The samples are collected at particular time interval and the % In-vitro drug Release was Determined. The drug release was evaluated by RP-HPLC method with Chromatographic Conditions of a stainless steel column (10cm x4.6cm, 5µm) Using methanol and buffer at 50:50 volumes as Mobile phase at Flow rate 1.0 ml/min with detection wavelength 254 nm. Based on the obtained test results, the results meets the acceptance criteria, Among different dissolution medium’s The drug substance is less soluble in pH 4.5 acetate Buffer medium and pH 6.8 Phosphate Buffer medium Then 0.1 N hydrochloric Acid medium and 0.1 N hydrochloric Acid with 2% SLS medium and The dissolution profile for the test product Of Prazosin SR Tablets 5 mg (Generic Product) compared against the Reference sample ( Prazopill XL 5) is found satisfactory Which is Compared in terms of difference factor (f1) and similarity factor (f2). In conclusion, the study focused on the sustained-release formulation of Prazosin 5 mg tablets has successfully demonstrated the appropriateness of drug release characteristics when compared to the reference product. Through testing and analysis, we have established that the sustained-release mechanism in the generic formulation aligns closely with the reference product, ensuring the intended release profile of the active ingredient. This finding holds significance not only in terms of meeting regulatory standards but also in assuring healthcare practitioners, patients, and regulatory bodies of the therapeutic consistency and efficacy of the generic formulation compared to the reference product.

Keywords: Prazosin Hydrochloride 5mg Sustained release tablet (Generic and Reference Product), Comparative evaluation of In-vitro drug release, % of drug release, RP-HPLC method.