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Current Pharmaceutical Analysis

Editor-in-Chief

ISSN (Print): 1573-4129
ISSN (Online): 1875-676X

Research Article

Quality by Design Based Method Development for Simultaneous Estimation of Montelukast Sodium and Theophylline in Tablet Dosage Form

Author(s): Kunti Abhishek Shah and Vijaykumar Kunvarji Parmar*

Volume 15, Issue 6, 2019

Page: [612 - 623] Pages: 12

DOI: 10.2174/1573412914666180827143700

Price: $65

Abstract

Background: Analytical Quality by design (AQbD) is one of the upcoming regulatory requirements in the field of pharmaceutical analysis for the development of reliable and robust analytical methods. Montelukast sodium and theophylline available in tablet dosage forms are used widely for the treatment of airway disorders. Liquid chromatographic methods for estimation of the drugs are reported but those chromatographic methods developed by the AQbD approach are not available.

Methods: A systematic design of experiments has been employed to develop a liquid chromatographic method for simultaneous estimation of montelukast sodium and theophylline. Critical process parameters are defined and optimization of methanol content in mobile phase, the concentration of trifluoroacetic acid and flow rate was employed within the framework of the full factorial design. The statistical analysis of the experimental data for critical quality attributes namely tailing factor of both the drugs and resolution was performed.

Results: A multi-dimensional design space for the critical process parameters was obtained. The optimal chromatographic separation of the two API was achieved using C18 (250mm×4.6mm, 5µm) column as stationary phase and mobile phase composed of acetonitrile, trifluoroacetic acid (TFA) (0.2%v/v in water) and methanol in the ratio of 25:15:60 (v/v/v) at flow rate of 1.0 ml min-1. The influence of the CPP was evaluated by various data tables for example, analysis of variance and lack of fit. Interpretation of various plots obtained from the experimental data such as predicted vs. actual, predicted vs. run, pareto chart, perturbation plot and contour plot provided the information on the manner in which each factor affects the critical quality attributes.

Conclusion: A design space generated by design of experiments is an evidence for the robustness of the method. The assay results show the applicability of the method for analysis of commercially available tablets.

Keywords: Montelukast, theophylline, HPLC, quality by design, design of experiments, tablet dosage.

Graphical Abstract
[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

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