کد مقاله | کد نشریه | سال انتشار | مقاله انگلیسی | نسخه تمام متن |
---|---|---|---|---|
2495667 | 1116076 | 2011 | 6 صفحه PDF | دانلود رایگان |
عنوان انگلیسی مقاله ISI
Validation of a simple RP-HPLC method developed for the quantification of meta-cresol in parathyroid hormones formulation
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کلمات کلیدی
موضوعات مرتبط
علوم زیستی و بیوفناوری
بیوشیمی، ژنتیک و زیست شناسی مولکولی
پزشکی مولکولی
پیش نمایش صفحه اول مقاله

چکیده انگلیسی
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 x 250 mm L, porosity 300 Ã
, particle size 5 μm) with a guard column (reversed- phase C18 column of 4.6 mm ID x 12.5 mm L, porosity 300 Ã
, 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; âge 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 within-and 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.
ناشر
Database: Elsevier - ScienceDirect (ساینس دایرکت)
Journal: Pharmaceutical Methods - Volume 2, Issue 3, JulyâSeptember 2011, Pages 203-208
Journal: Pharmaceutical Methods - Volume 2, Issue 3, JulyâSeptember 2011, Pages 203-208
نویسندگان
Shaligram S. Rane, Alkesh Ajameri, Rustom Mody, P. Padmaja,