Abstract
DEVELOPMENT AND VALIDATION OF A STABILITY-INDICATING RP-HPLC ASSAY METHOD AND STRESS DEGRADATION STUDIES ON DAPIPRAZOLE HYDROCHLORIDE IN OPHTHALMIC DOSAGE FORM

*Kumaraswamy Gandla, K. Harathi, M. Ravinder and Gade. Narmada

ABSTRACT

A simple, rapid, accurate, precise, robust and reproducible reverse phase high performance liquid chromatographic method was developed for the determination of Dapiprazole in pure drug and pharmaceutical dosage form. The quantification was carried out using enable Inertsil ODS-3Vs column in a binary mode with mobile phase comprising of Acetonitrile: Methanol:Buffer (50:30:20) in the ratio of 50:30:20 %v/v at flow rate 1.0 mL/min, detection was carried out at 243 nm using UV-Visible detector with injection volume 20μl, the retention time was found to be 3.438min. The proposed method was validated as per ICH guidelines. The method produced linear response in the concentration range of 1-5μg/ml (R2 0.999). The recovery studies were carried out and found to be within101%. %RSD was found to be 2%. LOD and LOQ of Dapiprazole for the method were found to be 3.64μg/ml and 11.04μg/ml respectively. The proposed method was statistically evaluated and can be applied for the routine analysis, quality control of raw materials, formulation of different strengths, dissolution studies and bioequivalence studies for the same formulation of Dapiprazole.

Keywords: Dobutamine; RP–HPLC; Validation; Stability indicating: Ophthalmic Dosage form.


[Full Text Article]

Login





Forgot Password  |  Register

Indexing

Best Paper Awards

European Journal of Biomedical and Pharmaceutical Sciences (EJBPS) will give best paper award in every issue in the form of money along with certificate to promote research activity of scholar.

Best Article of current issue :

Dr. Dhrubo Jyoti Sen

Download Article : Click here

News & Updation

  • EJBPS: AUGUST ISSUE PUBLISHED

    AUGUST 2022 Issue has been successfully launched on 1 August 2022.

  • EJBPS New Impact Factor

    Its our Pleasure to Inform you that EJBPS Impact Factor has been increased from 5.467 to 6.044, due to high quality Publication at International Level.

  • Index Copernicus Value

    EJBPS Received Index Copernicus Value 77.3, due to High Quality Publication in EJBPS at International Level

  • Journal web site support Internet Explorer, Google Chrome, Mozilla Firefox, Opera, Saffari for easy download of article without any trouble.

    .

  • Article Invited for Publication

    Dear Researcher, Article Invited for Publication  in EJBPS coming Issue.

     

UG/PG/Ph.D Research Publication

Research Scholar of UG/PG/Ph.D can Submit their Research Article/Review Article/Case Study/Short Communication for Publication in EJBPS

Downloads

Copyright From

Covering Letter

                        Author Instruction 
 

PLAGERLUM REPORT