Vignaduzzo S E, Castellano P M, Kaufman T S
Institute of Chemistry, Rosario (IQUIR, CONICET-UNR), Suipach 513, 52002LRK, Rosario, Argentine.
Indian J Pharm Sci. 2010 Mar;72(2):197-203. doi: 10.4103/0250-474X.65033.
The association of meloxicam and pridinol is indicated for treating muscular contractures and low back pain. A dissolution test for the meloxicam-pridinol combined tablet formulation was developed and validated, using a suitable HPLC method for simultaneously quantitating both dissolved drugs. The optimized conditions include the use of USP apparatus 2 at a paddle rotation rate of 75 rpm and 900 ml of 50 mM phosphate buffer (pH= 7.5) as dissolution medium, at 37.0±0.5°. The test, which demonstrated to be robust against small changes in bath temperature, paddle rotation speed and pH of the dissolution medium, was applied to two different brands of tablets; the corresponding dissolution profiles were constructed and both brands showed to dissolve at least 75% of the drugs at the 45 min time point.
美洛昔康与丙哌利多联用适用于治疗肌肉挛缩和腰痛。采用一种合适的高效液相色谱法同时定量两种溶解药物，开发并验证了美洛昔康 - 丙哌利多复方片剂的溶出度试验。优化条件包括使用美国药典装置2，桨板转速为75转/分钟，900毫升50毫摩尔/升磷酸盐缓冲液（pH = 7.5）作为溶出介质，温度为37.0±0.5°。该试验对溶出介质的浴温、桨板转速和pH值的微小变化具有稳健性，应用于两个不同品牌的片剂；构建了相应的溶出曲线，两个品牌在45分钟时间点均显示至少75%的药物溶解。
