Validated UV Spectrophotometric and HPTLC Method for Determination of Fosamprenavir Calcium in Pharmaceutical Formulation

Research Article

Austin J Anal Pharm Chem. 2015; 2(4): 1049.

Validated UV Spectrophotometric and HPTLC Method for Determination of Fosamprenavir Calcium in Pharmaceutical Formulation

Pekamwar SS¹*, Bhavar GB², Aher KB² and Kakad SJ²

¹Department of Pharmaceutical Chemistry, School of Pharmacy, Swami Ramanand Teerth Marathwada University, India

²Department of Pharmaceutical Chemistry, Amrutvahini College of Pharmacy, India

*Corresponding author: Pekamwar SS, Department of Pharmaceutical Chemistry, School of Pharmacy, Swami Ramanand Teerth Marathwada University, India.

Received: August 22, 2015; Accepted: September 14, 2015; Published: September 18, 2015

Abstract

A simple, rapid and precise, UV spectrophotometric and High Performance Thin Layer Chromatographic (HPTLC) methods were developed and validated for quantitative determination of Fosamprenavir calcium in bulk and pharmaceutical formulations. In UV spectrophotometric method, estimation of Fosamprenavir calcium was carried out using 0.5 N Hydrochloric acids as solvent at 262.8 nm. The drug obeyed Beer–Lambert’s law in the concentration range of 2–90 μg/mL with coefficient of correlation (R²) of 0.9997. In the HPTLC method, the chromatographic development was carried out on HPTLC plates precoated with silica gel 60 F254 using Methanol as mobile phase. Detection was carried out at 270 nm. The Rf value of drug was 0.69 ± 0.01. The calibration curve was linear over a range of 200–800 ng/spot with a regression coefficient of 0.996. Both the methods were validated as per ICH guideline with respect to linearity, accuracy, precision, robustness etc. The methods can be adopted in routine analysis of Fosamprenavir Calcium in tablet dosage form.


Keywords: Fosamprenavir Calcium; HPTLC method; UV method; Validation

Abbreviations

SD: Standard Deviation; RSD: Relative Standard Deviation; ICH: International Conference on Harmonization.

Introduction

Fosamprenavir Calcium, chemically (3S)-Tetrahydro-3-furyl {(αS)-α-[(1R)-1-hydroxy-2-(N1-isobutylsulfanilamido) ethyl] phenethyl} carbamate calcium phosphate (Figure 1), is a novel antiretroviral drug. Fosamprenavir calcium is one of the most recently approved HIV-1 protease inhibitor and is rapidly and extensively converted to amprenavir after oral administration. It is administrated orally with a dose of 700 mg two times a day [1-5].