NON-DESTRUCTIVE RAMAN SPECTROSCOPIC METHOD FOR ESTIMATION OF MONTELUKAST FROM TABLET DOSAGES FORM

Jwal Doctor; Palak Thakkar; Mitul Prajapati; Nrupresh Patel; Priti J. Mehta

doi:10.22159/ijpps.2017v9i6.14043

Authors

Jwal Doctor Department of Pharmaceutical Analysis, Institute of Pharmacy, Nirma University, Sarkhej-Gandhinagar Highway Ahmedabad- 382481, Gujarat, India
Palak Thakkar Department of Pharmaceutical Analysis, Institute of Pharmacy, Nirma University, Sarkhej-Gandhinagar Highway Ahmedabad- 382481, Gujarat, India
Mitul Prajapati Department of Pharmaceutical Analysis, Institute of Pharmacy, Nirma University, Sarkhej-Gandhinagar Highway Ahmedabad- 382481, Gujarat, India
Nrupresh Patel Department of Pharmaceutical Analysis, Institute of Pharmacy, Nirma University, Sarkhej-Gandhinagar Highway Ahmedabad- 382481, Gujarat, India
Priti J. Mehta Department of Pharmaceutical Analysis, Institute of Pharmacy, Nirma University, Sarkhej-Gandhinagar Highway Ahmedabad- 382481, Gujarat, India

DOI:

https://doi.org/10.22159/ijpps.2017v9i6.14043

Keywords:

Nondestructive Raman spectroscopy, ICH guidelines, Montelukast Sodium

Abstract

Objective: A rapid, non-destructive and non-solvent raman spectroscopic method for estimation of Montelukast from tablet dosages form

Methods: Quantification was carried out by measuring the intensity of analyte peak at 1440 cm^-1. Each Raman spectrum corresponded to an accumulation of 4 scans with an exposure time of 5 sec for each scan with a total integration time of 20 sec.

Results: The method exhibited linearity between 2 mg-24 mg show well resolve quantification From MON. The linearity equation was calculated as y = 13.036x+70.819 and the correlation coefficient was found to be 0.997 for MON. LOD (limit of detection) and LOQ(limit of quantification) values were calculated using the calibration curve slope and standard deviation of the response. The LOD (limit of detection) and LOQ (limit of quantification) values were found to be 1.71 mg and 5.13 mg respectively.

Conclusion: The developed method was successfully applied for assay of montelukast in the intact formulation. The method was validated according to an international conference on harmonisation guidelines. A recent study, montelukast sodium had been analysed by the raman method, but, looking into the tremendous potential of raman spectroscopic method; it can be extended as a process analysis and technology tool in various quality checks during manufacturing of pharmaceutical products.

Downloads

Download data is not yet available.

References

J Muiller, K Knop, P Kleinebudde. Validation of Raman spectroscopic procedure in agreement with ICHguildline Q2with considering the transfer to real-time monitoring of an active coating process. J Pharma Biome Anal 2010;53:884-94.

Mbinze JK, SacrÃ© PY, Yemoa A. Development, validation and comparison of NIR and Raman methods for the identification and assay of poor-quality oral quinine drops. J Pharm Biomed Anal 2015;111:21-7.

Hong Ju He, Da-Wen Sun. Microbial evaluation of raw and processed food products by visible/infrared, Raman and fluorescence spectroscopy. Trends Food Sci Tech 2015;2:199-210.

Philippe Bourgeta, Alexandre Amina, Fabrice Vidala, Christophe Merlette. The contribution of Raman spectroscopy to the analytical quality control of cytotoxic drugs in a hospital environment: Eliminating the exposure risks for staff members and their work environment. Int J Pharm 2014;1-2:70-6.

AO Izolani, MT De Moraes, Claudio A, Tellez S. Fourier transform Raman spectroscopy of drugs: quantitative analysis of 1 phenyl-2,3 dimethyl-pyrazole-4 methylamino methene sodium sulfonate: (dipyrane). John Wiley Sons L T D 2003;34:837-43.

Pharmacopia I. Indian Pharmacopoeial Commission on behalf of Govt. of Indian Ministry of Health and family welfare; 2010. p. 849.

K Pallavi, PS Babu. Validated UV spectroscopic method for estimation of montelukast sodium from bulk and tablet formulation. Int J Pharm Biol Sci 2012;1:434-7.

YS Li, JS Church. Raman spectroscopy in the analysis of food and pharmaceutical nanomaterials. J Food Drug Anal 2014;22:29-48.

BD Patel, PJ Mehta. An overview: application of Raman spectroscopy in the pharmaaceutical field. Curr Pharm Anal 2010;6:131-41.

SG Skoulika. CAG rapid quantitative determination of ciprofloxacin in pharmaceutical by use of solid state FT-Raman spectroscopy. Appl Spectrosc 2001;55:1259-65.

Hasan Murat VelioÄŸlu, Havva TÃ¼may Temizb. Differentiation of fresh and frozen-thawed fish samples using Raman spectroscopy coupled with chemometric analysis. J Food Chem 2015;172:283-90.

RM Singh, PK Saini, SC Mathur, GN Singh. Development and validation of a RP-HPLC method for montelukast sodium in bulk and in tablet dosages form. Indian J Pharm Sci 2010;72:235-7.

Gudi G, KrÃ¤hmer A, Koudous I. Infrared and Raman spectroscopic methods for characterization of Taxus baccata improved taxane isolation by accelerated quality control and process surveillance. J Talanta 2015;143:43-9.

Saerens L, Segher N, Vervaet C, Remon JP, De Beer T. Validation of an in-line Raman spectroscopic method for continuous active pharmaceutical ingredient quantification during pharmaceutical hot-melt extrusion. Anal Chim Acta 2014; 806:180-7.

Jun Zhanga, Ye Yingc. Raman spectroscopy for in-line and off-line quantification of poorly soluble drugs in strip films. Int J Pharm 2014;1-2:428-37.

Sylwester Mazurek, R Szostak. Quantification of atorvastatin calcium in tablets by FT-raman spectroscopy. J Pharm Biomed Anal 2009;1:168-72.

ICH Guidelines for Validation of Analtical Procedure: Text and Methodology Q2(R1), International Conference on Hormonization Geneva, Switzerland; 1995.

ICH Guidline for Validation of Analytical Procedure: Methodology, International Conference on Hormonization; 1996.

SG Skoulika. CAG rapid noninvasive quantitative determination of acyclovir in pharmaceutical solid dosages forms through their poly (vinyl chloride) blister package by soild state fouier transform raman spectroscopy. Appl Spectrose 2003;57:407-12.

R Szostask. SM quantitative determination of acetylsalicylic acid and acetaminophen in tablet by FT raman spectroscopy. Analyst 2002;127:144-8.