%0 Journal Article
%T A validated stability indicating HPLC method for the determination of process-related impurities in pantoprazole bulk drug and formulations
%A Saurabh Pandey
%A Preeti Pandey
%A Durgesh Mishra
%A Umesh Kumar Singh
%J Brazilian Journal of Pharmaceutical Sciences
%D 2013
%I Universidade de S?o Paulo
%X A stability-indicating high-performance liquid chromatographic (HPLC) method was developed with short run time and validated for the assay of process related impurities of pantoprazole in bulk form. Resolution of drug, its potential impurities and degradation products were achieved on a Hypersil ODS column utilizing a gradient with 0.01 M phosphate buffer of pH 7 and acetonitrile as eluent, at the detection wavelength of 290 nm. Flow rate was set at 1 mL min-1. The procedure was found to be specific, linear (r=0.999), recovery (97.9-103%), LOD (0.043-0.047 ¦ÌgmL-1), LOQ (0.13-0.14 ¦ÌgmL-1) and robust. Acceptable robustness indicates that the assay method remains unaffected by small but deliberate variations. Pantoprazole was found to degrade in acidic, oxidative and under photolytic stress conditions. The drug was stable to alkaline and dry heat conditions. This method has been successively applied to pharmaceutical formulation and no interference from the excipients was found. Desenvolveu-se m¨¦todo indicador de estabilidade por Cromatografia a L¨ªquido de Alta Efici¨ºncia (CLAE) com pequeno tempo de corrida e validado para o ensaio de impurezas relacionadas ao processo de produ  o de pantoprazol em batelada. A determina  o do f¨¢rmaco, de suas impurezas potenciais e dos produtos de degrada  o foi realizada com coluna de ODS Hypersil, utilizando gradiente com tamp o de fosfato 0,01 M pH 7 e acetonitrila como eluente, no comprimento de onda de detec  o de 290 nm. A velocidade de fluxo foi fixada em 1 mLmin-1. O procedimento se mostrou espec¨ªfico, linear (r=0,999), com recupera  o (97,9-103%), LOD (0,043-0,047 ¦ÌgmL-1), LOQ (0,13-0,14 ¦Ìg mL-1) e robusto. Robustez aceit¨¢vel indica que o m¨¦todo de ensaio n o ¨¦ afetado por varia  es pequenas, exceto as planejadas. O pantoprazole degradou em condi  es ¨¢cidas, oxidativas e sob condi  es de estresse fotol¨ªtico. O f¨¢rmaco foi est¨¢vel em condi  es alcalinas e de calor seco. Este m¨¦todo tem sido sucessivamente aplicado ¨¤ formula  o farmac¨ºutica e n o se encontrou interfer¨ºncia de excipientes.
%K Cromatografia L¨ªquido de Alta Efici¨ºncia
%K Cromatografia L¨ªquido de Alta Efici¨ºncia
%K Pantoprazol
%K High performance liquid chromatography
%K High performance liquid chromatography
%K Pantoprazole
%U http://www.scielo.br/scielo.php?script=sci_arttext&pid=S1984-82502013000100019