Determination of Venlafaxine in Bulk and Pharmaceutical Formulations Using Stability Indicating RP-HPLC Method with UV Detector

Author(s): Satish S. Reddi, Gautam Singhvi*, Archana Khosa, Kowthavarapu V. Krishna, Ranendra N. Saha.

Journal Name: Current Pharmaceutical Analysis

Volume 15 , Issue 3 , 2019

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Abstract:

Background: A robust and validated analytical method is a key component at various stages of pharmaceutical product development to ensure identity, purity and quality of drugs and formulations.

Objective: The aim of proposed work was to develop and validate a simple, sensitive and stability indicating high performance liquid chromatographic method for the estimation of venlafaxine hydrochloride in bulk and formulations for routine analysis as well as for preformulation studies.

Methods: Efficient chromatographic separation has been performed on a HpyercloneTM 5µm BDS C18 column using a mobile phase consisting of a mixture of phosphate buffer (25 mM, pH 3.0) and acetonitrile (70:30 v/v) at a flow rate of 1 ml min-1. Venlafaxine hydrochloride was analyzed using UV detector at 225nm. Developed method was validated as per ICH guidelines.

Results: The method has demonstrated linearity over the range of 100 to 2000 ng ml-1 with regression equation, mean peak area (y) = 93.32 x concentration - 322.00 (R2 = 1). The method has demonstrated good and consistent recovery (99.34 to 101.16%). Precision of the method reflected by the relative standard deviation values at intra-day and inter-day levels was less than 1.79%. The detection and quantitation limits were 6.55 ng ml-1 and 19.84 ng ml-1 respectively indicating sensitivity of the method. The method was successfully applied for the estimation of venlafaxine hydrochloride in marketed and inhouse formulations. Also, developed method was successfully used in drug-excipients compatibility studies for VEN.

Conclusion: The method was found to be accurate, precise, sensitive and selective for the determination venlafaxine hydrochloride in bulk and pharmaceutical formulations.

Keywords: Venlafaxine, stability indicating, high performance liquid chromatography, analytical method, validation. drugexcipient compatibility.

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Article Details

VOLUME: 15
ISSUE: 3
Year: 2019
Page: [258 - 265]
Pages: 8
DOI: 10.2174/1573412914666171228162205
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