Research Journal of Pharmaceutical Dosage Forms and Technology
  • Year: 2014
  • Volume: 6
  • Issue: 1

ICH Guideline Practice-a Validated Stability-Indicating HPLC Method for the Determination of Efavirenz in Dosage Form

  • Author:
  • T. Gopi Raju2,, M. Gayatri Ramya1,, A. Rajesh3, S. Kathirvel3, Sanjay Kumar Gupta4
  • Total Page Count: 8
  • Page Number: 7 to 14

1Department of Pharmaceutics, Acharya Nagarjuna University, Nagarjuna Nagar-522 510

2Department of Pharmaceutical Chemistry, Telangana University, Nizamabad – 503322,

3Department of Pharmaceutics and Pharmaceutical Analysis, Hindu College of Pharmacy, Guntur -522002,

4Department of Pharmaceutics, Shadan College of Pharmacy, Hyderabad, Andhra Pradesh -500008

*Corresponding Author E-mail: rajuph111@gmail.com

**Address for correspondence: M. Gayatri Ramya, Department of Pharmaceutics, Acharya Nagarjuna University, Nagarjuna Nagar-522 510

Online published on 29 May, 2014.

Abstract

A simple, precise, accurate and new stability-indicating reversed-phase high-performance liquid chromatographic (RP-HPLC) method was developed and validated as per International Conference on Harmonisation (ICH) of Technical Requirements for Registration of Pharmaceuticals for Human Use guidelines to determine efafirenz in tablet dosage form. The drug was successfully eluted at 6.264 min by mixture of ammonium dihydrogen phosphate buffer, acetonitrile and triethylamine (30:70:1) on C18 column (150 mm × 4.6 mm, 5 μm) at the flow of 1.5 ml/min. Drug content was determined in between 99.79% and 100.33% with standard deviation of 0.217. The validated RP-HPLC method may be successfully applied for assay, dissolution studies, bio-equivalence studies, as well as routine analysis in pharmaceutical industries.

Keywords

RP-HPLC, Efavirenz, ICH