Development and Validation of a Stability Indicating HPLC Assay Method for Determination of Warfarin Sodium in Tablet Formulation

Publish Year: 1398
نوع سند: مقاله ژورنالی
زبان: English
View: 360

This Paper With 18 Page And PDF Format Ready To Download

  • Certificate
  • من نویسنده این مقاله هستم

استخراج به نرم افزارهای پژوهشی:

لینک ثابت به این Paper:

شناسه ملی سند علمی:

JR_CHM-3-2_004

تاریخ نمایه سازی: 20 مهر 1398

Abstract:

The objective of the current study was to developed simple, precise and accurate isocratic reversed-phase stability indicating high performance liquid chromatography [HPLC] assay method validated the for determination of warfarin in solid pharmaceutical dosage forms. Isocratic reversed phase high performance liquid chromatography [RP-HPLC] separation was achieved on a SGE SS wakosil (150 mm × 4.6 mm i.d., C8RS 5 µm particle size) column using mobile phase of acetonitrile and 50 mM sodium hydrogen phosphate dibasic dihydrate buffer pH 3.0 (50:50 v/v) at a flow rate of 1.0 mL min-1, the injection volume was 20.0 μL and the detection was carried out at 280 nm using photo-diode array detector. The drug was subjected to oxidation, hydrolysis, photolysis and heat in order to apply stress condition. The method was validated for specificity, linearity, precision, accuracy, robustness and solution stability. The method was linear in the drug concentration range of 40-160 μg mL-1 with a correlation coefficient 0.9995. The precision (relative standard deviation RSD) amongst six-sample preparation was 0.22% for repeatability and the intermediate precision [RSD] amongst six-sample preparation was 0.70%. The accuracy (recovery) was between 99.95 and 99.15%. Degradation products produced as a result of stress studies did not interfere with detection of warfarin and the assay can thus be considered stability indicating. 

Keywords:

Warfarin , Stability indicating assay , HPLC method development and validation

Authors

Vijay R. Ram

Department of Chemistry, KSKV Kachchh University, Bhuj-۳۷۰ ۰۰۱, Gujarat, India

Kapil L. Dubal

Department of Chemistry, Saurashtra University, Rajkot-۳۶۰ ۰۰۵, Gujarat, India

Pragnesh Dave

Department of Chemistry, KSKV Kachchh University, Bhuj-۳۷۰ ۰۰۱, Gujarat, India

Hitendra S. Joshi

Department of Chemistry, Saurashtra University, Rajkot-۳۶۰ ۰۰۵, Gujarat, India

مراجع و منابع این Paper:

لیست زیر مراجع و منابع استفاده شده در این Paper را نمایش می دهد. این مراجع به صورت کاملا ماشینی و بر اساس هوش مصنوعی استخراج شده اند و لذا ممکن است دارای اشکالاتی باشند که به مرور زمان دقت استخراج این محتوا افزایش می یابد. مراجعی که مقالات مربوط به آنها در سیویلیکا نمایه شده و پیدا شده اند، به خود Paper لینک شده اند :
  • Link K.P. Circulation., 1959, 19:97 ...
  • Holbrook A.M., Pereira J.A., Labiris R., McDonald H., Douketis J.D., ...
  • Ansell J., Hirsh J., Polle L., Bussey H., Jacobson A., ...
  • Naidong W., Ring P.R., Midtlien C., Jiang X. J. Pharm.  ...
  • Locatelli I., Kmetec V., Mrhar A., Grabnar I. J. Chromat., ...
  • HouJ., Zheng J., Shamsi S.A. J. Chromat. A, 2007, 1159:208 ...
  • Huang C., Yang J., Du Y., Miao L. Clin. Chimica ...
  • McCormick T.J., Gibson A.B., Diana F.J. J. Pharm.  Biomed. Anal., ...
  • Suganthi A., Ravi T.K, Chem. Method., 2019, 3:43  ...
  • نمایش کامل مراجع