The USFDA guidelines now stress the pharmaceutical companies to file an ANDA which is QbD compliant. So, the pharmaceutical companies show a keen interest in leaning the principles of QbD. QbD refers to the achievement of certain predictable quality with desired and predetermined specifications. The present study describes the development and subsequent validation of an RP-HPLC method for the separation of paracetamol (PCM), tapentadol (TAP) and aceclofenac (ACE) in combination dosage form by application of QbD approach. A 33 full factorial design based on systematic scouting of three factors of RP- HPLC method (pH, mobile phase ratio and flow rate) was presented to study the effects on dependant variables, namely, peak area, number of theoretical plates and tailing factor. A pilot study was performed for obtaining the working range of 3 variable parameters. The statistical evaluation of the results was carried out by design Expert software. Contour and 3D surface plots were obtained and an overlay plot was generated, which showed a wide majority of yellow region indicative of a wide area of design space. Thus one can conclude that the selected range gave robust results. The optimized chromatographic condition was achieved on Enable C18 analytical column with phosphate buffer pH 6.3: methanol (35:65) as the mobile phase and flow rate of 1 ml min-1. The validation of the proposed method was carried as per ICH Q2 (R1) guideline. The calibration graphs ranged from 75- 450 μg ml-1 for PCM, 5 - 30 μg ml-1 for TAP and 20-120 μg ml-1 for ACE.
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