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vol.61 número2DEVELOPMENT AND VALIDATION OF HPTLC METHOD FOR SIMULTANEOUS ESTIMATION OF TERBINAFINE HYDROCHLORIDE AND MOMETASONE FUROATE IN COMBINED DOSAGE FORMSYNTHESIS OF ORGANOPHOSPHORUS COMPLEXES AND STRUCTURAL CHARATERIZATION OF TWO DIMERIC TRIPHENYLPHOSPHINNE COMPLEXES OF MERCURY(II) IONS FROM DIMERIC COMPLEXES OF [4-METHYLBENZOYLMETHYLENETRI-P-TOLYLPHOSPHINE MERCURY(II) HALIDES índice de autoresíndice de assuntospesquisa de artigos
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Journal of the Chilean Chemical Society

versão On-line ISSN 0717-9707

Resumo

AHMAD, AJAZ et al. BOX-BEHNKEN SUPPORTED DEVELOPMENT AND VALIDATION OF ROBUST RP-HPLC METHOD: AN APPLICATION IN ESTIMATION OF PRAVASTATIN IN BULK AND PHARMACEUTICAL DOSAGE FORM. J. Chil. Chem. Soc. [online]. 2016, vol.61, n.2, pp.2963-2967. ISSN 0717-9707.  http://dx.doi.org/10.4067/S0717-97072016000200022.

Pravastatin, a natural bioactive compound inhibits cholesterol biosynthesis which is isolated from fungus by fermentation process. A rapid, sensitive and robust novel reversed phase-HPLC method with UV detection set at 238 nm was developed and validated for quantification of pravastatin in pure drug form and pharmaceutical formulation (Pravachol). A liquid-liquid extraction technique was applied for the preparation samples and chromatographic separation was performed on Symmetry® C (5pm, 3.9 x 150 mm) column with a retention time of 1.95 min using isocratic elution of mobile phase. The mobile phase used in this work consisted of a mixture of methanol and phosphate buffer (70:30%, v/v, pH 4) which was delivered at a flow rate at 1.5 ml/min. Developed HPLC-UV method was validated for linearity (R2 = 0.999), accuracy, precision, sensitivity, system suitability, selectivity, and robustness. Box-Behnken experimental design was applied in the validation of robustness. Three independent variables such as the composition of mobile phase, flow rate and pH of mobile phase were investigated. The results indicated that a slight change in the mobile phase composition and flow rate affects the responses, while pH had no significant effect on the response. Overall, the proposed HPLC-UV method was found to be simple, sensitive, and highly robust for routine analysis of pravastatin.

Palavras-chave : Pravastatin; RP-HPLC; Box-Behnken; Robustness; Peak area.

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