Development and validation of spectrophotometric method for estimation of anastrozole bulk and pharmaceutical dosage formulation

Authors

  • Sathis Kumar D Senior Lecturer, Dept. of Pharmaceutical Analysis, Nalanda College of pharmacy, Nalgonda-508 001. Andhra Pradesh, India
  • Harani A Dept. of Pharmaceutical Analysis, Nalanda College of pharmacy, Nalgonda-508 001. Andhra Pradesh, India
  • Rohit reddy T Dept. of Pharmaceutical Analysis, Nalanda College of pharmacy, Nalgonda-508 001. Andhra Pradesh, India
  • Sucharitha G1 Dept. of Pharmaceutical Analysis, Nalanda College of pharmacy, Nalgonda-508 001. Andhra Pradesh, India
  • Krishna. P Dept. of Pharmaceutical Analysis, Nalanda College of pharmacy, Nalgonda-508 001. Andhra Pradesh, India
  • Priyanka sagar J Dept. of Pharmaceutical Analysis, Nalanda College of pharmacy, Nalgonda-508 001. Andhra Pradesh, India

Keywords:

Anastrozole, Spectrophotometer, Method development, Validation

Abstract

A simple, precise and accurate method was developed and validated by using a simple solvent system for anastrozole bulk and tablet dosage form. In the developed method, water and ethanol are used as solvents. The λmax was determined to be 221nm. The procedure was validated as per ICH rules for Accuracy, Precision, Detection limit, Linearity, Reproducibility and Quantitation limit. The linearity concentration range was 40-60µg/mL with the correlation coefficient of 0.9971. The percentage recovery for anastrozole was found to be 98.6 to 100.8%. Limit of detection and limit of quantitation values were found to be 1µg/mL and 3µg/mL. The method has been successfully used to analyze commercial solid dosage containing 1mg of anastrozole with good recoveries and proved to be robust.

References

Susan Budavari, The Merck Index an

encyclopaedia of chemicals, drugs and

biologicals, 12th edition, Merck & Co., Inc,

NJ, 1996.

Drugs, 2002; 62(17):2483-2490.

Plourde PV, Review of pharmacology,

clinical pharmacodynamics. Breast cancer

res. treat. 30,103-111.

Berzas J J, Rodriguez J, Contento A M and

Cabello M P, Determination of drugs used in

advanced breast cancer by capillary gas

chromatography of pharmaceutical

formulations. Journal of Separation Science,

, 26(9): 915-922.

Saravanan G, Suryanarayana M V, Jadhav

M J, Ravikumar M, Someswararao N and

Acharyulu P V R , A stress stability

behaviour and development of an LC assay

method for anastrozole. Chromatographia,

, 66: 435-438.

Duan G L, Liang J Y and Zuo M, Rapid

determination of anastrozole in plasma by

gas chromatography with electron capture

detection and its application to an oral

pharmacokinetic study in healthy volunteers.

Biomedical chromatography, ISSN 0269-

Mendas G D, Hamamoto D, Ilha J, Pereira A

D S and Nucci G D, Anastrozole

quantification in human plasma by high

performance liquid chromatography coupled

to photospray tandem mass spectrometry

applied to pharmacokinetic studies. J

chromatogr B, 2007, 850: 553-559.

Rodriguez J, Berzas J J, Castaneda G and

Rodriguez M I, Micellar electrokinetic

capillary chromatographic method for

simultaneous determination of drugs used to

treat advanced breast cancer.

Chromatographia, 2002, 56:283-288.

Sean C Sweetman. Martindale, The

complete drug reference. 33rd edition. p:

Mendham J, Denney R C, Barnes J D and

Thomas M J K, Vogel’s Textbook of

quantitative chemical analysis. 6th edition.

Pearson Education, Singapore. p: 117-169.

Agarwal O P. Advanced practical organic

chemistry. Goel publishling house. p: 44.

Vogel I. Elementary practical organic

chemistry, part 2: Qualtitative organic

analsis. 2th edition. CBS Publishers and

Distributors, Delhi. p: 114.

David AWilliams and Thomas L Lemke.

Foye’s Principles of medicinal chemistry, 5th

edition. Lippincott Willams and wilkins. p:

Hobard H.Willard, Lynne L.Merrit Jr., John

A Dean, Frank A.Settle, Jr. Instrumental

methods of analysis, 7th edition. CBS

publishers and distributors, New Delhi.

Sethi P D. Quantitative chemical analysis of

drugs in pharmaceutical formulations, 2nd

edition. CBS publishers and distributors,

New Delhi. p: 150.

Organisation of Pharmaceutical procedures

of India; validation – Chapter 7.0. [cited

Saturday, February 14, 2009] Available at

http://www.indiaoppi.com/publication.asp

Text on validation of analytical procedures

ICH harmonised tripartite guidelines. [cited

Saturday, February 14, 2009] Available at

http://www.ich.org/cache/compo/363-272-

html

Downloads

Published

09/30/2020

Issue

Section

Original Research Articles