Abstract

Palakurthi Ashok Kumar¹, Dongala Thirupathi¹, Y Ravindra Kumar¹ and Anireddy Jayashree²

DOI : http://dx.doi.org/10.13005/ojc/330349

A stability indicating QbD based gradient method was developed and validated with the concept of quality by design (QbD) and with help of design of experiments (DoE) tool for the simultaneous determination of related organic impurities of Ibuprofen and Paracetamol in a combination solid oral dosage form by reverse phase high performance liquid chromatography (RP-HPLC). The most important critical quality attributes (CQA) of the developed test method were chosen and were evaluated by using “Design-Expert® 8” software tool with a quadratic mode of central composite design (CCD). The separation between all known impurities was achieved using “X-Terra RP18, 250-mm × 4.6-mm, 5-µm column with a 1.0 mL/min flow rate of gradient elution. The UV detection wavelength was used as 220 nm. The method validation is carried out as per ICH guidance, and the parameters include precision, accuracy, specificity, linearity, detection limit (DL), quantitation limit (QL), and robustness.

Paracetamol; QbD; Design of experiments

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