Mon, 18 Dec 2017

Development and Validation of Stability Indicating HPTLC Method for Estimation of Palonosetron Hydrochloride

Mrinalini C. Damle1*, Anshu A. Agrawal1

1. Department of Quality Assurance, AISSMS College of Pharmacy, Kennedy Road, Near R.T.O., Pune-411001, Maharashtra, India.


ABSTRACT

A simple and sensitive stability indicating HPTLC method has been developed and validated for estimation of Palonosetron hydrochloride. Separation of the drug was carried on aluminium plates precoated with silica gel 60 F254 using Ethyl acetate: Methanol: Triethylamine (6:3:1 v/v/v) as mobile phase. The retention factor (Rf) for Palonosetron hydrochloride was found to be 0.50 ± 0.04. The detection was carried at 242 nm. Stress testing of Palonosetron hydrochloride was carried out according to the International conference on harmonization (ICH) guideline Q1A (R2). The drug was subjected to acid, base, neutral hydrolysis, oxidation, thermal degradation and photolysis. Palonosetron hydrochloride showed considerable degradation under oxidative condition. The method was successfully validated according to ICH guidelines Q2 (R1). The data of linear regression analysis indicated a good linear relationship over the range of 250–1500ng/band concentrations with correlation coefficient 0.994. The accuracy of the method was established based on the recovery studies. The LOD and LOQ were 11.81ng/band and 35.78ng/band respectively.

Keywords: Palonosetron hydrochloride, High Performance Thin Layer Chromatography (HPTLC), Validation, Stability-Indicating Method.


[PDF]  Viewed: 686  Downloaded: 87
  • Call for paper

    American Journal of PharmTech Research (AJPTR) is a peer-reviewed, bimonthly official international journal allowing access to abstracts and full-text.

    Read more...

     

  • Email & SMS Alerts

    Email/SMS alert system is one of the key features and gives update information about the submitted manuscript.

    Read more...

  • Article Statastics

    American Journal of PharmTech Research (AJPTR) provides unique facility for authors to know popularity of articles on basis of numbers of PDF download and views. It will display in tabulated format.

  • Online Submission

    American Journal of PharmTech Research (AJPTR) is one of the International open access journal devoted to various disciplines in science and technology.

    Read more...

web counter
web counter