JOURNAL OF CHILEAN CHEMICAL SOCIETY

Vol 61 No 2 (2016): Journal of the Chilean Chemical Society
Original Research Papers

BOX-BEHNKEN SUPPORTED DEVELOPMENT AND VALIDATION OF ROBUST RP-HPLC METHOD: AN APPLICATION IN ESTIMATION OF PRAVASTATIN IN BULK AND PHARMACEUTICAL DOSAGE FORM

Ajaz Ahmad
Department of Clinical Pharmacy, College of Pharmacy, King Saud University, P.O. Box 2457, Riyadh 11451
Mohammad Raish
Department of Pharmaceutics, College of Pharmacy, King Saud University, P.O. Box 2457, Riyadh 11451
Khalid M. Alkharfy
Department of Clinical Pharmacy, College of Pharmacy, King Saud University, P.O. Box 2457, Riyadh 11451
Kazi Mohsin
Department of Pharmaceutics, College of Pharmacy, King Saud University, P.O. Box 2457, Riyadh 11451
Faiyaz Shakeel
Department of Pharmaceutics, College of Pharmacy, King Saud University, P.O. Box 2457, Riyadh 11451 Center of Excellence in Biotechnology Research (CEBR), King Saud University, P.O. Box 2460, Riyadh 11451
Vol 61, No 2 (2016): Journal of the Chilean Chemical Society
Published June 10, 2016
Keywords
  • Pravastatin,
  • RP-HPLC,
  • Box-Behnken,
  • Robustness,
  • Peak area
How to Cite
Ahmad, A., Raish, M., Alkharfy, K. M., Mohsin, K., & Shakeel, F. (2016). BOX-BEHNKEN SUPPORTED DEVELOPMENT AND VALIDATION OF ROBUST RP-HPLC METHOD: AN APPLICATION IN ESTIMATION OF PRAVASTATIN IN BULK AND PHARMACEUTICAL DOSAGE FORM. Journal of the Chilean Chemical Society, 61(2). Retrieved from https://jcchems.com/index.php/JCCHEMS/article/view/23

Abstract

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® C18 (5μm, 3.9 × 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.

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