Formulation of Solid Dosage Form Containing Clopidogrel and Cilostazol and Its HPLC Analysis

Abstract

Objective: The verify now P2Y12 assay suggested that addition of cilostazol to clopidogrel proves to be efficious in the treatment of patients with cardiovascular disease (CVD). Based on these findings, an attempt has been made to formulate solid dosage form containing the two drugs at the recommended concentrations and develop and validate reverse phase high-performance liquid chromatography (HPLC) method for their simultaneous estimation. Methods:A combined tablet dosage form containing cilostazol (100 mg) and clopidogrel (75 mg) was formulated by direct compression method. A reverse phase HPLC method using C8 column, employing 0.025M phosphate buffer: methanol: acetonitrile (20:40:40% v/v) as mobile phase at a flow rate of 1 ml/min with ultraviolet (UV) detection at 237 nm was developed and validated as per International Council on Harmonisation (ICH) guidelines. Results:The prepared powder blend showed excellent flow properties and formulated tablet passed the standard tests for tablets. The tablets were suitably analyzed by the reverse phase HPLC method with a retention time (RT) of 3.82 and 7.72 min for cilostazol and clopidogrel respectively. The method exhibited linearity (10-100µg/ml for cilostazol and 7.5-75µg/ml for clopidogrel) with r 2 = 0.999 for both drugs respectively. The recoveries of cilostazol and clopidogrel were 98.97% and 98.94% respectively. The relative standard deviation (RSD) was<2% indicating good method precision. The stability indicating properties evaluated by forced degradation studies showed good separation of the drugs from their degradation products. Conclusion:A simple, precise, robust, stability-indicating HPLC method was developed for simultaneous assay of cilostazol and clopidogrel in prepared tablet formulation and validated as per ICH guidelines. This method can be employed for the analysis and stability studies of solid dosage forms containing the two drugs.

Simultaneous Estimation and Forced Degradation Studies of Amiloride Hydrochloride and Furosemide in a Pharmaceutical Dosage Form Using Reverse-Phase High-Performance Liquid Chromatography Method

“…System suitability was performed by injecting six replicate injections of the standard solution (100%), and parameters such as peak area, USP tailing, theoretical plates, retention time, and peak asymmetry were evaluated. The % relative standard deviation (RSD) was determined and reported within the limits [10]. The results are shown in Table 2.…”