[1]
Martindale. The Extra Pharmacopoeia, 31st ed; Pharmaceutical Press: London, 2002.
[2]
United States Pharmacopoeia National Formulary 34th ed.; United States Pharmacopeial convention press: New York,. , 2011.
[4]
Siddiqui, M.R.; Alothman, Z.A.; Rahman, N. Analytical techniques in pharmaceutical analysis: A review. Arab. J. Chem., 2017, 10, S1409-S1421.
[5]
Alothman, Z.A.; Rahman, N.; Siddiqui, M.R. Review on pharmaceutical impurities, stability studies and degradation products. Rev. Adv. Sci. Eng., 2013, 2, 155-166.
[6]
Rahman, N.; Azmi, S.N.H.; Wu, H.F. The importance of impurity analysis in pharmaceutical products: an integrated approach. Accredit. Qual. Assur., 2006, 11, 69-74.
[7]
Rajesh, V.; Anupama, B.; Jagathi, V.; Varaprasad, K. High performance thin layer chromatographic method for estimation of Erlotinib hydrochloride as buk drug. Int. J. Biol. Med. Res., 2011, 2, 433-435.
[8]
Usha Rani, G.; Chandrasekhar, B.; Devanna, N. Extractive colorimetric method development and validation for Erlotinib in bulk and tablet dosage form. J. Appl. Pharm. Sci., 2011, 1, 176-179.
[9]
Rajesh, V.; Jagathi, V.; Sindhuri, K.; Devala Rao, G. Spectrofluorimetric method for the estimation of erlotinib hydrochloride in pure and pharmaceutical formulations. E-J. Chem., 2011, 8, S304-S308.
[10]
Erin, R.L.; Swain, S.M.; Tan, A.R.; Fiqq, W.D.; Sparreboom, A. Liquid chromatographic determination of erlotinib, an epidermal growth factor receptor tyrosine kinase inhibitor. J. Chromatogr. B., 2003, 796, 181-188.
[11]
Yadav, N.K.; Raghuvanshi, A.; Sharma, G.; Sharma, G.; Beg, S.; Katare, O.P.; Nanda, S. QbD-Based development and validation of a stability indicating HPLC Method for Estimating Ketoprofen in bulk drug and proniosomal vesicular system. J. Chromatogr. Sci., 2015, 54(3), 377-389.
[12]
Latha, S.T.; Ananda Thangadurai, S.; Jambulingam, M.; Sereya, K.; Kamalakannan, D.; Anilkumar, M. Development and validation of RP-HPLC method for the estimation of Erlotinib in pharmaceutical formulation. Arab. J. Chem., 2017, 10, S1138-S1144.
[13]
Ferreira, S.L.C.; Bruns, R.E.; Ferreira, H.S.; Matos, G.D.; David, J.M.; Brandao, G.C.; Silva, E.G.P.; Portugal, L.A.; Dos Reis, P.S.; Souza, A.S.; Dos Santos, W.N.L. Box-Behnken design: An alternative for the optimization of analytical methods. Anal. Chim. Acta, 2007, 597(2), 179-186.
[14]
Massart, D.L.; Vandeginste, B.G.M.; Buydens, L.M.C.; Jong, S.; Lewi, P.J.; Smeyers-Verbeke, J. Handbook of Chemometrics and Qualimetrics: Part A; Elsevier: Amsterdam, 1977.
[15]
International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use.ICH, Q1A (R2): Stability Testing of New Drug Substances and Products (revision 2), International Conference on Harmonization., Geneva, Switzerland, February. 2003.
[16]
Blessy, M.; Ruchi, D.P.; Prajapati, P.N.; Agrawal, Y.K. Development of forced degradation and stability indicating studies of drugs- A review. J. Pharm. Anal., 2014, 4(3), 159-165.
[17]
Reynolds, D.W.; Kevin, L.F.; Mullaney, J.F.; Alsante, K.M.; Todd, D.H.; Michael, G.M. Available guidance and best practices for conducting forced degradation studies. Pharm. Technol., 2002, 26(2), 48-56.
[18]
U.S. Department of Health and Human Services.Food and drug administration, Centre for Drug evaluation and Research (CDER), centre for Biologics Evaluation and Research (CBER). Guidance for industry, Q2 (R1) Validation of Analytical Procedures: Methodology International Conference on Harmonization, Geneva November. 2005.
[19]
International Conference of Harmonization for Technical requirements for the Registration of Drugs for Human use. ICH, Q2B Validation of Analytical Procedure; Methodology, Geneva, Switzerland,May 1997.
[20]
International Federation of Pharmaceutical Manufactures and Associations (IFPMA) Validation of analytical procedures: text and methodology. Proceedings of the International Conference on Harmonization, Methodology Q2 (R1) Geneva, Switzerland. ICH,Switzerland: 1996.