engleski

The Use of 1H-qNMR for Determination of Benzoyl Peroxide in Gel Suspension – a Pilot Study

Clindamycin hydrochloride (CP) and benzoyl peroxide (BPO) are pharmaceutically active substances whose combination in gel suspension (AAG) is used in treatment of mild to moderate acne.1 According to the pharmaceutical regulation it is necessary to quantify the amount of CP and BPO in the marketed product. While the amount of CP is easily quantifiable, determination of the exact quantity of BPO is a challenge due to its lack of homogeneity. Drug substance BPO is naturally nonhomogeneous: it is a mixture of water and anhydrous BPO, where hydrophobic BPO is prone to rearrangement to minimize physical contact with water. Using the dry BPO is also not an option since it must contain at least 20.0 % of water to prevent its explosivity.2 Since homogeneity of the analytical standard is a critical factor which especially impacts the accuracy of the analysis, the goal of this study was to avoid the external BPO standard and develop a qNMR3 method for quantification of BPO in gel suspension using CP as internal standard.

qNMR ; benzoyl peroxide

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