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

  • Samina Alam Jinnah University for Women, Karachi Pakistan.
  • Saima Saleem Jinnah University for Women, Karachi Pakistan.
  • Safila Naveed Jinnah University for Women, Karachi Pakistan.
  • Huma Dilshad Jinnah University for Women, Karachi Pakistan.
  • Fatima Qamar Jinnah University for Women, Karachi Pakistan.
  • Tanweer Alam Drug Regulatory Authority, Government of Pakistan
  • Halima Sadia Jinnah University for Women, Karachi Pakistan.
  • Sidra khan Jinnah University for Women, Karachi Pakistan.
  • Mariam Karim Jinnah University for Women, Karachi Pakistan.
  • Amanullah Khan Drug Testing laboratory ,Quetta, Health Department, Baluchistan
Keywords: atorvastatin calcium, API and pharmaceutical formulation, method development, HPLC

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.

Author Biographies

Samina Alam, Jinnah University for Women, Karachi Pakistan.

Faculty of Pharmacy

Saima Saleem, Jinnah University for Women, Karachi Pakistan.

Faculty of Pharmacy

Safila Naveed, Jinnah University for Women, Karachi Pakistan.

Faculty of Pharmacy

Huma Dilshad, Jinnah University for Women, Karachi Pakistan.

Faculty of Pharmacy

Fatima Qamar, Jinnah University for Women, Karachi Pakistan.

Faculty of Pharmacy

Halima Sadia, Jinnah University for Women, Karachi Pakistan.

Faculty of Pharmacy

Sidra khan, Jinnah University for Women, Karachi Pakistan.

Faculty of Pharmacy

Mariam Karim, Jinnah University for Women, Karachi Pakistan.

Faculty of Pharmacy

Amanullah Khan, Drug Testing laboratory ,Quetta, Health Department, Baluchistan

Drug Testing laboratory 

Published
2018-04-19