Development and Validation of the Ultraviolet Spectrophotometric Method for Determination of Erlotinib Hydrochloride
Abstract
A simple, accurate, novel, safe, and precise method was developed for the estimation of erlotinib hydrochloride in tablet dosage form using a mixture of methanol and acetonitrile (50:50% V/V). The maximum and subsidiary peak absorption of erlotinib hydrochloride were noted at 247 and 333 nm, respectively. Erlotinib hydrochloride follows Beer’s law in the concentration range of 5–30 μg/mL (r2 = 0.9992). In the proposed method, the subsidiary peak absorption wavelength of 333 nm was used to estimate the concentration of erlotinib hydrochloride in tablets. The linear regression equation was found to be y = 0.0461x + 0.0164. The developed method was validated according to the International Conference on Harmonization (ICH) guidelines, and the values of accuracy, precision, and other statistical variables were found to be in accordance with the prescribed values.
About the Authors
R. A. JadavIndia
Khadia, State-Gujarat, India
M. A. Ambasana
India
Khadia, State-Gujarat, India
A. H. Bapodra
India
Khadia, State-Gujarat, India
References
1. http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021743s010lbl.pdf.
2. V. Ashok Chakravarthy, B. B. V. Sailaja, Europ. J. Pharm. Med. Res., 3, No. 12, 609–624 (2016).
3. K. Sereya, S. T. Latha, D. Kamalakannan, M. Jambulingam, M. Anilkumar, S. Ananda Thangadurai, Int. J. Pharm. Health Care Res., ISSN: 2306-6091, 1, No. 1, 23–27 (2013), www.ijphr.com.
4. M. Mathrusri, Annapurna, B. Venkatesh, R. Krishna Chaitanya, Chem. Sci. Transact., 3, No. 2, 840–846 (2014), doi: 10.7598/cst2014.828.
5. Camille Wermuth, David Aldous, Pierre Raboisson, Didier Rognan, The Practice of Medicinal Chemistry, 4th ed. (2015), doi: 10.1016/C2012-0-03066-9.
6. S. T. Latha, S. AnandaThangadurai, M. Jambulingam, K. Sereya, D. Kamalakannan, M. Anilkumar. Arab. J. Chem., 10, No. 1, S1138–S1144 (2017), doi: 10.1016/j.arabjc.2013.02.006.
7. Soheila Bolandnazar, Adeleh Divsalar, Hadi Valizadeh, Arash Khodaei, Parvin Zakeri-Milani, Adv. Pharm. Bull., 3, No. 2, 289–293 (2013), doi: 10.5681/apb.2013.047.
8. V. S. Saravanan, B. Mallikarjuna Rao, J. Drug Delivery Therap., 3, No. 1, 50–54 (2013).
9. Anna Svedberg, Henrik Green, Anders Vikström, Joakim Lundeberg, Svante Vikingsson, J. Pharm. Bio-med. Anal., 107, 186–195 (2015), doi: 10.1016/j.jpba.2014.12.022.
10. Takahiro Suga, Miki Shimada, Masamitsu Maekawa , Hiroyuki Suzuki, Masaru Mori, Tatsuma Okazaki, Akira Inoue, Hiroaki Yamaguchi, Nariyasu Mano, Chromatography, 38, 95–100 (2017), doi: 10.15583/jpchrom.2017.007.
11. V. Rajesh, B. Anupama, V. Jagathi, K. Varaprasad, Int. J. Biol. Med. Res., 2, No. 1, 433–435 (2011), www.biomedscidirect.com.
12. Int. Conf. Harmonization Guidelines, Validation of Analytical Procedures: Text and Methodology Q2(R1).
13. B. Babu, S. N. Meyyanathan, B. Gowramma, S. T. Narenderan, Int. J. Chem. Tech. Res., 10, No. 15, 183–188 (2017), www.sphixsai.com.
Review
For citations:
Jadav R.A., Ambasana M.A., Bapodra A.H. Development and Validation of the Ultraviolet Spectrophotometric Method for Determination of Erlotinib Hydrochloride. Zhurnal Prikladnoii Spektroskopii. 2022;89(2):369-373.