Pharmaceutical industries use dissolution testing as a quality control measure in determining the in vitro release of active pharmaceutical ingredients (APIs) of solid oral dosage forms. One of the most frequently used lipid-lowering drugs (Ciprofibrate) does not have an official dissolution procedure covered in pharmacopeial monographs. The research was carried out to develop and analytically substantiate a dissolution procedure specifically for ciprofibrate tablets that would contain 100 mg of the API. Ciprofibrate was studied stabilities toward sink at 37°C in three media of dissolution, namely, phosphate buffer (pH 6.8), borate buffer (pH 8.0), and 0.1 N hydrochloric acid. Dissolution studies were carried out in vitro at different conditions by application of USP Apparatus 2 (paddle method), and special consideration was given to the effects of deaeration and filtration. The optimum and maximum discriminating form of dissolution was found to be 900 mL of phosphate buffer (pH 6.8) at 37.8 (C) with 75 rpm on stirring, 60 min. A validated UV spectrophotometric assay measured the release of ciprofibrate, and this solution was linear in the calibration range of 10–60 g/mL (r 2 = 0.999). The developed dissolution method is easy to use, repeatable, and has been validated as accurate, precise, and linear. It can, therefore, be used in routine quality control and a batch release test of ciprofibrate 100 mg tablets.
Anamika Singh (Tue,) studied this question.