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Development and validation of RP-HPLC and RP-UPLC methods for quantification of parathyroid hormones (1-34) in medicinal product formulated with meta-cresol

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Journal of Pharmaceutical Analysis 2012年第2期2卷 136-142页

作者： Shaligram S.Rane Alkesh Ajameri Rustom Mody P.Padmaja Department of Applied Chemistry Faculty of Technology and EngineeringThe Maharaja Sayajirao University of BarodaVadodaraGujaratIndia intas biopharmaceuticals ltd. AhmedabadIndia Department of Chemistry Faculty of ScienceThe Maharaja Sayajirao University of BarodaVadodaraGujaratIndia

Rapid and sensitive reversed phase high performance liquid chromatography (RP-HPLC) and ultra performance liquid chromatography (RP-UPLC) method with UV detection has been developed and validated for quantification of parathyroid hormone (PTH) in presence of meta-cresol as a stabilizer in a pharmaceutical *** was performed with mobile phase containing 0.1% Trifluoroacetic acid (TFA) in MilliQ water and 0.1% TFA in acetonitrile with gradient program and flow rate at 0.3 mL/min for HPLC and 0.4 mL/min for *** was accomplished with internal reference standard (qualified against innovator product and National Institute for Biological Standards and Control (NIBSC) standard).The methods were validated for linearity (correlation coefficient 0.99),range,accuracy,precision and *** was confirmed by considering three factors;mobile phase composition,column temperature and flow rate/age of mobile *** precision was confirmed on different equipments,different columns and on different *** relative standard deviation (RSD) (<2% for RP-HPLC and <1% for UPLC,n=30) indicated a good *** time was found about 17 min and 2 min by HPLC and UPLC methods,*** methods are simple,highly sensitive,precise and accurate and have the potential of being useful for routine quality control.

关键词： Parathyroid hormone Reversed phase high performance liquid chromatography Ultra performance liquid chromatography Validation Meta-cresol

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