[1]
International Conference on Harmonization of Technical Requirements
for Registration of Pharmaceuticals for Human Use, ICH
Harmonised Tripartite Guideline (2009) Pharmaceutical development
Q8 (R2). ICH, Geneva
[2]
International Conference on Harmonization (ICH) of Technical
Requirements for Registration of Pharmaceuticals for Human Use,
ICH Harmonised Tripartite Guideline (2005) Quality risk management
Q9. ICH, Geneva
[3]
International Conference on Harmonization (ICH) of Technical
Requirements for Registration of Pharmaceuticals for Human Use, ICH Harmonised Tripartite Guideline (2008) Pharmaceutical quality
system Q10. ICH, Geneva
[4]
Nayak, A. A review of montelukast in the treatment of asthma and allergic rhinitis. Exp Opin. Pharmacother., 2004, 5, 679-686.
[5]
Weinberger, M.D. Theophylline for treatment of asthma. J. Pediatr., 1978, 92, 1-7.
[6]
Criag, C.R.; Stitzel, R.E. Modern pharmacology and clinical applications.
6th Ed.; Lippincott Williams and Wilkins: Baltimore,
United States: 463.
[7]
Patel, R.B.; Parmar, R.R.; Patel, V.M.; Shah, D.A. Simultaneous estimation of montelukast sodium and theophylline in pharmaceutical dosage form by uv spectrophotometric method. Int. J. Instit. Pharm. Life Sci., 2012, 2, 150-160.
[8]
Sangeetha, M.; Mahendran, C. Development and validation of HPTLC method for simultaneous estimation of montelukast and theophylline in bulk and pharmaceutical dosage form. J. Chem. Pharm. Res., 2016, 8, 203-208.
[9]
Jain, P.; Rajoriya, V.; Kashaw, V. Development and validation of simultaneous RP-HPLC method for the estimation of theophylline and motelukast in pharmaceutical formulation. Anal. Lett., 2015, 5, 172-182.
[10]
Chauhan, P.H.; Jani, H.D.; Luhar, S.V.; Pirani, N.A. Development and validation of analytical method for simultaneous estimation of theophylline and montelukast in pharmaceutical dosage form. J. Pharm. Sci. Bioscientific Res., 2016, 6, 315-321.
[11]
Sripalakit, P.; Kongthong, B.; Saraphanchotiwitthaya, A. A simple bioanalytical assay for determination of montelukast in human plasma: Application to a pharmacokinetic study. J. Chromatogr. B, 2008, 869, 38-44.
[12]
Challa, B.R.; Awen, B.Z.; Chandu, B.R.; Khagga, M.; Kotthapalli, C.B. Method development and validation of montelukast in human plasma by HPLC coupled with ESI-MS/MS: application to a bioequivalence study. Sci. Pharm., 2010, 78, 411-422.
[13]
Patel, N.K.; Subbaiah, G.; Shah, H.; Kundlik, M.; Sanyal, M.; Shrivastav, P.S. Rapid determination of montelukast in human plasma by LC-ESI-MS/MS and its application to a bioequivalence study. Anal. Lett., 2009, 42, 2041-205209.
[14]
Ranjan, O.P.; Nayak, U.Y.; Reddy, M.S.; Dengale, S.J.; Musmade, P.B.; Udupa, N. Development and validation of RP-HPLC method with ultraviolet detection for estimation of montelukast in rabbit plasma: Application to preclinical pharmacokinetics. J. Young Pharm., 2013, 5, 133-138.
[15]
Garg, L.K.; Reddy, V.S.; Sait, S.S.; Krishnamurthy, T.; Vali, S.J.; Reddy, A.M. Quality by design: design of experiments approach prior to the validation of a stability-indicating hplc method for montelukast. Chromatographia, 2013, 76, 1697-1706.
[16]
Eldin, A.B.; Shalaby, A.A.; Tohamy, M.E. Development and validation of a HPLC method for the determination of montelukast and its degradation products in pharmaceutical formulation using an experimental design. Acta. Pharm. Sci., 2011, 53, 45-56.
[17]
Popovich, D.J.; Butts, E.T.; Lancaster, C.J. The analysis of theophylline by HPLC. J. Liq. Chromatogr. Relat. Technol., 1978, 1, 469-478.
[18]
Narin, I.; Sarioglan, S.; Anilanmert, B.; Sari, H. pKa determinations for montelukast sodium and levodropropizine. J. Solution Chem., 2010, 39, 1582-1588.
[19]
Florey, K. Analytical Profiles of drug substances Volume 4. New York: Academic press, 477
,
[20]
International Conference on Harmonization (ICH) of Technical
Requirements for Registration of Pharmaceuticals for Human Use,
ICH Harmonised Tripartite Guideline (2005) Validation of analytical
procedures: Text and Methodology. Q2(R1). ICH, Geneva