Stability Kinetics of Imiquimod: Development and Validation of an Analytical Method.

08:00 EDT 16th May 2019 | BioPortfolio

Summary of "Stability Kinetics of Imiquimod: Development and Validation of an Analytical Method."

For a new immune modulator imiquimod, various liquid chromatography methods have been described in literature but all of them are deficient in one or other aspects of complete method development. The present work intends to develop and validate the stability indicating reverse phase high performance liquid chromatographic (HPLC) method. The isocratic flow of mobile phase comprising equal volume ratio of acetate buffer BP pH 3.7 and acetonitrile at the rate of 1.5 mL/min through the C-18 column at 25°C lead to elution of drug around 2.3 min when analyzed at 244 nm using UV-detector. The linear regression equation in calibration plot was y = 61632×-1224 with 0.9992 coefficient of determination (r2). The percent relative standard variation (% RSD) in peak area at low, mid and high region of linearity range was less than 5% in precision studies. The method was able to detect 0.039 μg/mL of drug but practical limit of quantitation (LOQ) was 1.5 μg/mL. The imiquimod molecule was stable in all except oxidizing conditions where it degraded into more polar molecule in hydrogen peroxide (H2O2) concentration dependent manner. Therefore, an analytical method capable of accurately and specifically estimating the drug in microgram range was successfully developed.


Journal Details

This article was published in the following journal.

Name: Journal of chromatographic science
ISSN: 1945-239X


DeepDyve research library

PubMed Articles [24748 Associated PubMed Articles listed on BioPortfolio]

Development and Validation of Stability Indicating UPLC-PDA/MS for the Determination of Imiquimod and its Eight Related Substances: Application to Topical Cream.

A stability indicating analytical method for imiquimod and its related impurities was developed by ultra-pressure liquid chromatography (UPLC) using design of experiments. This method could quantify i...

Flow Cytometry Method Validation Protocols.

Analytical method validation provides a means to ensure that data are credible and reproducible. This unit will provide a brief introduction to analytical method validation as applied to cellular anal...

Development and Validation of Multiple Reaction Monitoring (MRM) Assays for Clinical Applications.

Selected/multiple reaction monitoring-mass spectrometry (SRM/MRM) is an analytical method that is frequently combined to the use of stable isotope-labeled standard (SIS) peptides for absolute protein ...

Chirobiotic V Versus Chiralpak ID for the Enantioselective Chromatographic Separation of Chloroquine: Stability and Validation Study.

Chloroquine is a chiral antimalarial drug and demonstrates enantioselective pharmacodynamic and pharmacokinetic properties. However, this drug is administered as racemate. The knowledge of stereoselec...

Automated measurement of the erythrocyte sedimentation rate: method validation and comparison.

Background Development of automated analyzers for erythrocyte sedimentation rate (ESR) has imposed the need for extensive validation prior to their implementation in routine practice, to ensure compar...

Clinical Trials [6354 Associated Clinical Trials listed on BioPortfolio]

Bioequivalence of Generic Imiquimod Cream, 5% When Compared to Aldara™ (Imiquimod) Cream, 5% in the Treatment of Actinic Keratosis

At the end of the study, safety and efficacy outcome measures will be compared to determine a) if dosing with Generic Imiquimod cream, 5% is therapeutically equivalent to the currently mar...

Topical Imiquimod 5% Cream for Treatment of Cutaneous Neurofibromas in Adults With Neurofibromatosis 1

The purpose of this study is to determine if imiquimod cream can reverse the growth of neurofibromas. Imiquimod is a skin cream that works by stimulating the body's immune system to respo...

A Therapeutic Equivalence Study of Two Imiquimod Cream 5% Treatments for Patients With Actinic Keratosis

The primary objectives are to establish the therapeutic equivalence of imiquimod cream 5%, manufactured by Taro Pharmaceuticals Inc. and Aldara (imiquimod) cream, manufactured by 3M, and t...

Betaglucin 0.2% Versus Imiquimod 5% in Treatment of Ano-genital Warts: Combined Results From Triple Blind Controlled Study

In order to determine the Efficacy of Betaglucin 0.2% in gel vs Imiquimod 5% cream in the treatment of 102 individuals older than 18 years with anogenital warts trials in two arms 51 with ...

Imiquimod and Pembrolizumab in Treating Patients With Stage IIIB-IV Melanoma

This pilot trial studies the side effects and how well imiquimod and pembrolizumab work in treating patients with stage IIIB-IV melanoma. Imiquimod may stimulate the immune system. Monoclo...

Medical and Biotech [MESH] Definitions

An analytical method used in determining the identity of a chemical based on its mass using mass analyzers/mass spectrometers.

An analytical method for detecting and measuring FLUORESCENCE in compounds or targets such as cells, proteins, or nucleotides, or targets previously labeled with FLUORESCENCE AGENTS.

A solventless sample preparation method, invented in 1989, that uses a fused silica fiber which is coated with a stationary phase. It is used for sample cleanup before using other analytical methods.

An extraction method that separates analytes using a solid phase and a liquid phase. It is used for preparative sample cleanup before analysis by CHROMATOGRAPHY and other analytical methods.

A CHROMATOGRAPHY method using supercritical fluid, usually carbon dioxide under very high pressure (around 73 atmospheres or 1070 psi at room temperature) as the mobile phase. Other solvents are sometimes added as modifiers. This is used both for analytical (SFC) and extraction (SFE) purposes.

Quick Search


DeepDyve research library

Relevant Topics

Pharmacy is the science and technique of preparing as well as dispensing drugs and medicines. It is a health profession that links health sciences with chemical sciences and aims to ensure the safe and effective use of pharmaceutical drugs. The scope of...

Drug Discovery
Clinical Approvals Clinical Trials Drug Approvals Drug Delivery Drug Discovery Generics Drugs Prescription Drugs In the fields of medicine, biotechnology and pharmacology, drug discovery is the process by which drugs are dis...

Searches Linking to this Article