DEVELOPMENT AND VALIDATION OF ISOCRATIC RP-HPLC METHOD FOR DETERMINATION OF VENLAFAXINE IN BULK AND TABLET DOSAGE FORM
Journal Title: Asian J of Pharm Sci & Tech - Year 2015, Vol 5, Issue 1
Abstract
ABSTRACT A simple, specific, sensitive, convenient, accurate, rapid and reliable isocratic reverse phase high performance liquid chromatographic (RP-HPLC) method has been developed for the quantitative determination of Venlafaxine in bulk and in tablet dosage form. Chromatographic separation was carried out on a utilizing Welchrom C18 isocratic column, (250 mm × 4.6 mm i.d., 5.0 μm) as stationary phase with a mobile phase comprising a mixture of Acetonitrile: Water 50:50 v/v, with apparent pH of 3.3, at a flow rate of 1.0 mL/min and a UV detection at 226 nm. The retention time of Venlafaxine peak was found at 3.503 minutes. The developed was ascertained by evaluating various validation parameters such as linearity, precision, accuracy, Specificity, LOD and LOQ according to the International Conference on Harmonization ICH Q2 (R1) guidelines. The method was linear over the concentration range of 1-5µg/mL with correlation coefficient 0.9999. The limit of detection and limit of quantitation values were 0.0665 μg/mL and 0.199 μg/mL, respectively. The recovery studies were performed by standard addition method and mean percentage recoveries were found to be greater than 99 %. The amount of Venlafaxine in tablet dosage form was found to be 99.783 and the % RSD and 0.703 for intra-day and 0.479 for inter-day precision was 1.18 and the respective linear regression equation being y = 81.47 x + 0.833. Due to its simplicity, rapidness, high precision and accuracy, the proposed RP-HPLC method can be successfully and easily applied for routine analysis of Venlafaxine in bulk drug and tablet dosage form. Key words: RP-HPLC, Venlafaxine, Validation, ICH guidelines.
Authors and Affiliations
Panchumarthy*, Anusha Rani Kancherla, Devadasu Chapala
Keywords
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