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Validation of a simple RP-HPLC method developed for the quantification of meta-cresol in parathyroid hormones formulation

Submitted by webadmin on Fri, 10/21/2016 - 18:02
Pharmaceutical Methods,2011,2,3,203-208.
Published:July 2011
Type:Symposium - HPLC

Validation of a simple RP-HPLC method developed for the quantification of meta-cresol in parathyroid hormones formulation

Shaligram S. Rane, Alkesh Ajameri1, Rustom Mody1, P. Padmaja2

Departments of Applied Chemistry, Faculty of Technology and Engineering and Chemistry, Science Faculty,The Maharaja Sayajirao University of Baroda, Vadodara,

1Intas Biopharmaceuticals Ltd., Ahmedabad, Gujarat, India

2Department of Chemistry, Science Faculty, The Maharaja Sayajirao University of Baroda, Vadodara 39002, Gujarat, India. E-mail: p_padmaja2001@ yahoo.com

Abstract:

Aim : To develop and validate a rapid and sensitive reverse phase high performance liquid chromatography (RP-HPLC) method with UV detection for quantification of meta-cresol (m-cresol) in pharmaceutical preparation of parathyroid hormone (1–34) (PTH). Materials and Methods: Chromatography was performed on a Jupiter RP C-18 (4.6 mm ID × 250 mm L, porosity 300 Å, particle size 5 μm) with a guard column (reversedphase C18 column of 4.6 mm ID × 12.5 mm L, porosity 300 Å, particle size 5 μm) using a mobile phase containing 0.1% TFA in 60% methanol with isocratic program at 1.0 mL/ min flow rate. Detection was carried out at 217 nm. The method was validated as per ICH guidelines for linearity (correlation coefficient = 0.99), range, accuracy, precision, and robustness (n = 9 during accuracy parameter whereas n =15 during linearity and range parameter and n = 6 during repeatability). Robustness was confirmed by considering two factors; age effect of the mobile phase and test sample and with different columns during method development. Results : The method was linear over the concentration range of 75–120 μg/mL. The precision of the method in terms of relative standard deviation was evaluated from intra- and inter-day replicate injections of system suitability standards of m-cresol using different equipment and different columns. Components of withinand between-batch variances were found to be below 2% (n = 30) and 3%, respectively, which constituted an acceptable level of variation. Retention time was found to be about 5.2 min and 10.9 min for m-cresol and PTH, respectively. Conclusion:The developed method thus has the potential of being useful for routine quality control of m-cresol.