Development of validated stability-indicating HPTLC method for the estimation of ulipristal acetate in bulk and dosage form

Shruti Srivastava

doi:10.7324/japs.2021.1101120

Abstract

A Study of Method Development, Validation and Forced Degradation for Quantification of Buprenorphine Hydrochloride in a Microemulsion FormulationDhanashree Arun Mundhey, Vishal V. Rajkondawar, Anwar S. Daud, Nidhi P. Sapkal

Highlights

Chemical stability of pharmaceutical molecules is a matter of great concern as it affects the safety and efficacy of the drug product
The present study establishes the development of validated stability-indicating high performance thin layer chromatography method for the analysis of ulipristal acetate (UPA) in bulk and in dosage form with the help of the International Conference on Harmonization guidelines
It was further diluted 10 times with methanol to get the concentration of 100 μg ml−1 and further a 20–150 ng/spot concentration range was applied on thin layer chromatography (TLC) plate with Linomat V autosampler

Summary

INTRODUCTION

Chemical stability of pharmaceutical molecules is a matter of great concern as it affects the safety and efficacy of the drug product. Ulipristal acetate (UPA), chemically known as [17α-acetoxy-11β-(4-N, N-dimethyl amino-phenyl)-19norpregna-4,9-diene-3,20-dione] (Fig. 1), is a selective modulator of progesterone receptor. It is an emergency contraceptive used for uterine fibroids. High performance thin-layer chromatography (HPTLC) has emerged as an important tool for the analysis of various drugs and its substance. Due to several advantages, such as low running costs, high sample performance, it has become a standard analytical technique nowadays. The key benefit of HPTLC is that, unlike high-performance liquid chromatography (HPLC), it runs multiple samples using minimum mobile phase, thereby decreasing the cost per study and processing time (Abdel et al, 2014; Dhaneshwar, 2015; Zanwar et al, 2020; Zlatkis and Kaiser, 2011). The main objective of current study was to develop a sensitive and responsive stability-indicating method of HPTLC for UPA by using mobile phase dichloromethane: methanol (9.5:0.5; v/v), in accordance with the International Conference on Harmonization (ICH) guidelines

MATERIALS AND METHODS

Method development and validation

98.56 Specific

Findings

CONCLUSION