Introduction: Hydroquinone cream products is one of the best known treatments for skin hyperpigmentation. It acts by inhibiting the copper binding process of tyrosinase enzyme, thus decrease eomelanin and pheomelanin production, and consequently decrease the melanin synthesis. The objectives of the project is to establish, validate, and perform an appropriate HPLC stability-indicating assay for determining the hydroquinone content of a q4% hydroquinone, 1% hydrocortisone in cetomacrogol A baseq cream product manufactured in Guy's and St. Thomas' NHS trust production facility. -- Methodology: HPLC methodology was established and validated for its range, linearity, repeatability, precision, specificity, suitability of the used extraction method, and robustness. Stress degradation studies were also conducted as further confirmation of the specificity of the method. A batch of the cream product was manufactured under GMP, then packed in ten amber glass pots which were stored at different temperatures of 40AdC, 25AdC, and 4AdC. Pots stored at different temperatures were sampled on weekly basis and tested for their hydroquinone content and observed physical changes were recorded in terms of colour change and texture. -- Results: The established method passed all validation tests specified by the ICH. However, the extraction procedure was found sensitive, to extraction time. Cream pots stored at 4AdC was found to be the most stable, since it had the least degradation rate. All cream pots showed different levels of chromatic aberration depending on their storage temperature. Cream preparations stored at 4AdC and 25AdC were able to mentain their creamy texture over the 28 days of the study. -- Conclusion: Stability-indicating method for hydroquinone cream product was established and passed all ICH Q2 (Rl) guidelines specified validation parameters.-- Results: The established method passed all validation tests specified by the ICH. However, the extraction procedure was found sensitive, to extraction time.
|Title||:||Establishment and Validation of Stability-indicating Assay for Hydroquinone Cream Product Manufactured in Guy's and St. Thomas' NHS Trust|
|Author||:||Mohamed Hashad, King's College London. Department of Pharmacy|