HPLC Method Development and Validation of Atorvastatin Calcium in Bulk and Tablet Dossage Form

Abstract

Objective: The present work was aimed at the development of a simple, precise, rapid and selective RP-HPLC method for the estimation of Atorvastatin as API in both- bulk and pharmaceutical formulation.

Methods:The method was carried out on HPLC a C18 column (25 cm x 4.6 mm) with mobile phase consisting of methanol:water:acetonitrile: orthophosphoric acid (85:10:4, 1 v/v) and pH was adjusted to 3.2 with flow rate of 1.8 ml per min.Detection was carried out at 247 nm. Besides, all parameters were found to be under required limits including limits of detection and limits of quantification.Further,the method was developed and validated; linearity, accuracy, precision, ruggedness and robustness, through an efficient HPLC technique in accordance with the ICH validation guidelines.

Results:The results of all validated parameters - Linearity(r²= 0.999), Accuracy (101.5%) ,Precision, Ruggedness, Robustness, LOD (0.0008µg/ml) and LOQ (0.0002µg/ml) were found to be within required limits.

Conclusion:As per above discussion the developed method is in accordance with ICH guidelines and can be easily used for Bulk and pharmaceutical formulation testing.