Simultaneous Estimation and Validation of Niacin and Atorvastatin Calcium by UV-Spectroscopy in Pure and Tablet Dosage Form Using Methanol: Water Mixture as Solvent

Abstract

Purpose of This paper: Two simple, precise, rapid, sensitive and accurate simultaneous estimation by UV spectrophotometric methods were developed and validated for niacin (NCN) and atorvastatin calcium (ATR) in pure and tablet dosage form using methanol: water (40:60 v/v)mixture as solvent. Design and methodology: Two methods were developed, Method 1: was based on the simultaneous equation (Veroirdt's) method where as Method 2:was based on Q-analysis method. Findings: The absorption maxima were found to be 262 nm and 246 nm for niacin and atorvastatin calcium respectively. Both the drugs showed isosbestic point at 250 nm. Beer’s range was in the concentration range of 10-50 μg/ml for niacin and 4-20 μg/ml for atorvastatin calcium with correlation coefficient within the range of 0.9974 – 0.9998 for both the drugs. Recovery studies were performed to assess the accuracy of the methods, the results were found to be between 99.39 ± 0.7614 and 100.63 ± 0.3876 for niacin; 97. 71 ± 0.3131 and 99.06 ± 0.5625 for atorvastatin calcium. Research implications/limitations: The above two methods has been validated according to ICH guidelines. Practical implications: Hence the above methods can be used for routine analysis of NCN and ATR in pharmaceutical industries and research institutions.

Keywords

• Niacin
• Atorvastatin Calcium
• UV-Spectroscopy
• Beer’s Law
• Veroirdt’s Method
• Q-Analysis
• ICH.