ABSTRACT
OBJECTIVE: To explore the similarity of the dissolution curves of self-made and original telmisartan /hydrochlorothiazide tablets and provide basis for the prescription and process screening of self-made preparation and the quality similarity evaluation with original preparation. METHODS: The dissolution curves of telmisartan and hydrochlorothiazide from self-made and original preparations in four different dissolution media were determined using HPLC. The HPLC method was performed on Welch Ultimate XB-C8 column (4.6 mm × 250 mm, 5 μm) with mobile phase A consisting of ammonium dihydrogen phosphate solution (2.0 g ammonium dihydrogen phosphate was dissolved in 1 L water then adjusted to pH 3.0 with phosphoric acid) and mobile phase B consisting of acetonitrile- methanol (50:50) at a flow rate of 1.2 mL•min-1. The detection wavelength was set at 270 nm. The injection volume was 20 μL. Then f2 factor method was used to evaluate the similarity. RESULTS: The dissolution curves of self-made and original preparations of telmisartan /hydrochlorothiazide tablets in different dissolution media showed similarity, with the f2 factor ≥50 or the dissolution rate within 15 min≥85%. CONCLUSION: The dissolution behaviors of self-made and original telmisartan /hydrochlorothiazide tablets are basically similar, which indicates that the prescription and technology of self-made preparation are reasonable and feasible.
ABSTRACT
OBJECTIVE: To study the dissolution behavior of cilnidipine tablets, evaluate the consistency of dissolution behavior between three domestic products and the original tablets, and develop a new dissolution method with discriminatory power for prescription process. METHODS: The dissolution media were hydrochloric acid solution (pH 1.2), acetate buffer (pH 4.0), phosphate buffer (pH 6.8) and water, all containing 0.4% SDS. Using original tablets as the reference preparation, the dissolution curve of the test and reference preparations was compared by the similarity factor method. Apparatus 2 was used for the new method of dissolution test, using 900 mL phosphate buffer with 0.5% SDS (pH 6.8) as the dissolutive medium,at the rate of 75 r·min-1. The dissolution solution was taken at 60 min and analyzed by HPLC. The dissolution limit was set at 70%. RESULTS: For the three domestic pharmaceutical products, only one had consistent dissolution curves in the four dissolution media with the original product from Japanese Ajinomoto Co.. The new method of dissolution test could distinguish the products manufactured by advanced technology from those by process of general level. CONCLUSION: The new dissolution method has discriminatory power for prescription process of insoluble cilnidipine tablets when using phosphate buffer (pH 6.8) as the dissolutive medium, and the quality of the product can be effectively controlled.