The Use of Surrogate Reference Standards in Quantitative HPLC: a case Study of Griseofulvin and Cetirizine Hydrochloride

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2012
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A rapid and simple reverse-phase liquid chromatography method was developed and validated for the quantitative analysis of Griseofulvin and Cetirizine Hydrochloride using surrogate reference standards. Paracetamol, Ascorbic acid and Metronidazole were used as surrogate reference standards, for each of which a constant “k” was obtained. The isocratic liquid chromatography (LC) analysis for Griseofulvin was performed on C18 Phenomenex column (250 x 4.6mm) using mobile phase composed of methanol and water in a ratio of 70: 30 (v/v) at a flow rate of 1 ml/min with a UV detector set at 254nm. The mean retention time in minutes for Griseofulvin, Paracetamol, Ascorbic acid and Metronidazole were 3.65 ± 0.06, 2.47 ± 0.03, 1.70 ± 0.02 and 2.65 ± 0.04 respectively. The constant K obtained for Paracetamol, Ascorbic acid and Metronidazole in relation to Griseofulvin were 0.3824 ± 0.0077, 0.3317 ± 0.0048 and 1.0902 ± 0.0067 in that order. The isocratic LC analysis for Cetirizine hydrochloride was performed on C18 Phenomenex column (250 x 4.6mm) using mobile phase composed of methanol and sodium acetate buffer of pH 4.2 in a ratio of 60: 40 (v/v) at a flow rate of 1.5 ml/min with a UV detector set at 235nm. The mean retention times in minutes were 4.57 ± 0.06, 1.73 ± 0.05, 1.52 ± 0.04 and1.84 ± 0.04 for Cetirizine hydrochloride, Paracetamol, Ascorbic acid and Metronidazole respectively. The constant K obtained for Paracetamol, Ascorbic acid and Metronidazole in relation to Cetirizine hydrochloride were 0.3530 ± 0.0100, 0.3735 ± 0.0103, 0.4929 ± 0.0109 respectively. The analytical methods were validated according to the International Conference on Harmonization (ICH) guidelines. The methods showed linearity over the working range. The coefficient of variation for repeatability and intermediate precision were less than 2%. The methods were applied to commercial preparations. Statistical comparison of the v outcome and that from standard methods revealed that the methods can be used for routine analysis of Griseofulvin and Cetirizine hydrochloride since they were comparable
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A thesis submitted to the School of Graduate Studies, Kwame Nkrumah University of Science and Technology in partial fulfilment of the requirement for the award of Master of Philosophy in Pharmaceutical Analysis and Quality Control.
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