Author(s):
Yesha Nileshkumar Balar, Zarna R Dedania, Ronak R Dedania
Email(s):
zarna.dedania@bmusurat.ac.in
DOI:
10.52711/0974-360X.2023.00733 
Address:
Yesha Nileshkumar Balar*, Zarna R Dedania, Ronak R Dedania
Bhagwan Mahavir College of Pharmacy, Bhagwan Mahavir University, Nr. VIP Road, Vesu, Surat - 395017.
*Corresponding Author
Published In:
Volume - 16,
Issue - 10,
Year - 2023
ABSTRACT:
An accurate and precise and robust method has been described for Stability Indicating HPTLC method for development and validation for Bilastine and Montelukast in pharmaceutical dosage form. The separation carried out on silica gel 60F254 by using mobile phase of Toluene: Methanol 6.5:3.5 v/v. Linear regression shows a good in the range of 200-1200ng/spot and 100-600ng/spot for Bilastine and Montelukast with regression line equation y = 8.4512 X + 129.3 with r2 > 0.9985 and y = 5.6208 X + 2179.9 with r2 > 0.993. The 243nm was selected as detection wavelength. The Rf value was found to be 0.31±0.01 and 0.61±0.01 for Bilastine and Montelukast respectively. The Intraday precision was found to be 0.79–0.95% for Bilastine and 0.26–0.91% for Montelukast. The Interday precision was found to be 0.78–1.21% for Bilastine and 0.24–0.72% for Montelukast. Accuracy was performed by recovery study. The % recovery was found to be 99.49 to 101.78% for Bilastine and 98.6 to 101.76% for Montelukast. The LOD was found to be 26.26ng/spot for Bilastine and 33.34ng/spot for Montelukast. The LOQ was 79.60ng/spot for Bilastine and 99.64ng/spot for Montelukast. The Assay of Bilastine and Montelukast amount found to be 100.14% and 99.10% respectively. Forced Degradation studies were carried out at various conditions. In Acidic condition the % degradation of Bilastine and Montelukast was found to be 5.84% and 16.72% respectively. In Alkaline and Oxidative condition, the %degradation of Bilastine and Montelukast was found to be 26.95% and 17.61%. and 32.22% and 9.25% respectively. In Photolytic condition the %degradation was found to be 14.94% and 15.65% respectively for Bilastine and Montelukast. In Thermal condition the %degradation was found to be 17.54% and 14.65% respectively for Bilastine and Montelukast.
KEYWORDS: Bilastine, Montelukast, HPTLC, Stability Indicating Method.
Cite this article:
Yesha Nileshkumar Balar, Zarna R Dedania, Ronak R Dedania. A Validated Stability Indicating HPTLC Method for Bilastine and Montelukast in Pharmaceutical Dosage Form. Research Journal of Pharmacy and Technology 2023; 16(10):4498-4. doi: 10.52711/0974-360X.2023.00733
Cite(Electronic):
Yesha Nileshkumar Balar, Zarna R Dedania, Ronak R Dedania. A Validated Stability Indicating HPTLC Method for Bilastine and Montelukast in Pharmaceutical Dosage Form. Research Journal of Pharmacy and Technology 2023; 16(10):4498-4. doi: 10.52711/0974-360X.2023.00733 Available on: https://www.rjptonline.org/AbstractView.aspx?PID=2023-16-10-3
REFERENCES:
1. Lavorini F, Matucci A, Rossi O, Pistolesi M et al Concomitant Bilastine and Montelukast as additive therapy for seasonal allergic rhino conjunctivits and mild‐to‐moderate asthma. The Sky Study Allergy. 2020, 75, 675.
2. Drug bank https://go.drugbank.com/drugs/db11591 accessed in December 2020.
3. Sharma P, Gupta SK, Dahiya M et al. Method development and validation of Bilastine by HPLC. Int. J. Adv. Sci. 2020, 29, 13751 – 13758.
4. Bramptono.prran™-https://pdf.hres.ca/dpd_pm/00051878 accessed on December 2020.
5. Drug bank https://go.drugbank.com/drugs/db00471 accessed on December 2020.
6. Baokar S and Ranpise N. Analytical method development and validation for simultaneous estimation of Montelukast and Ebastine by HPLC. Res J Pharm Techno. 2015; 8: 1,5. doi: 10.5958/0974-360X.2015.00001.3
7. Prathyusha P and Sundararajan R. UV spectrophotometric method for determination of Bilastine in bulk and pharmaceutical formulation. Res J Pharm Tech. 2020; 13: 933-8. doi: 10.5958/0974-360X.2020.00176.6
8. Silva AT, Brabo GR, Marques ID, Bajerski I, Malesuik MD and Paim CS. UV spectrophotometric method for quantitative determination of Bilastine using experimental design for robustness. Drug Analytical Research. 2017; 1: 38-43. DOI: https://doi.org/10.22456/2527-2616.79221
9. Terzic J, Popovic I, Stajic A, Tumpa A and Jancic-stojanovic B. Application of analytical quality by design concept for Bilastine and its degradation impurities determination by hydrophilic interaction liquid chromatographic method. J. Pharm. Biomed. Anal. 2016; 125: 385-93. DOI: 10.1016/j.jpba.2016.04.022
10. Chowdhary A, Kota A and Syed. Method Development and Validation of new RP-HPLC method for the estimation of Bilastine in pharmaceutical dosage form, World J Pharm Sci. 2017; 6: 2297-2315.
11. Ouarezki R, Guermouche S and Guermouche M. Degradation kinetics of Bilastine determined by RP-HPLC method and identification of its degradation product in oxidative condition. Chemical Papers. 2020; 74: 1133-42. DOI: https://doi.org/10.1007/s11696-019-00956-x
12. Pardeshi P. P., Gaware V. M., Dhamak K. B. Development and Validation of RP-HPLC Method for the Estimation of Bilastine from bulk and Formulation. Asian J. Pharm. Ana. 2020; 10(2): 109-111. DOI: 10.5958/2231-5675.2020.00019.8
13. Khushbu K. Patel, Arati M. Patel, C. N. Patel. A new simple RP-HPLC Method development, Validation and Forced degradation studies of Bilastine. Asian Journal of Pharmaceutical Analysis. 2021; 11(3):183-7. DOI: 10.52711/2231-5675.2021.00031
14. Rambabu K, Narayana M, Ramasrinivas and Rao N. Stability indicating method development and validation for the determination of Bilastine and its impurities by UPLC method. IJPSR. 2020; 11: 1312-1321. http://dx.doi.org/10.13040/IJPSR.0975-8232.11(3).1312-21
15. Anuruddha R Chabukswar, Vishnu P. Choudhari , Shailesh N. Sharma, Nilesh A. Bari, Dhaval Ghuge. Ratio derivative spectrophotometry method for simultaneous estimation of Montelukast and Fexofenadine HCl in their combined dosage form. Asian J. Research Chem. 2012; 5(5): 637-641. DOI: 10.5958/0974-4150
16. Nikesh S. Rana, Rajesh K. S., Nikita N. Patel, Ujjaval Limbachiya, T.Y. Pasha. Derivative Spectrophotometric Method for Simultaneous Estimation of Montelukast Sodium and Ebastine in Bulk and Their Combined Tablet Dosage Form. Asian J. Research Chem. 2013; 6(3): 232-235. DOI: 10.5958/0974-4150
17. T. Raja, A. Lakshmana Rao. Quantitative Analysis of Levocetirizine Dihydrochloride and Montelukast Sodium in Tablets by High Performance Thin Layer Chromatography with Ultra Violet Absorption Densitometry. Asian J. Research Chem. 2012; 5(10): 1229-1233. DOI: 10.5958/0974-4150
18. Ramesh J, Jayalakshmi B, Vijayamirtharaj R, Arul Prakasam K.C.. Simultaneous Estimation of Montelukast Sodium and Levocetrizine Hydrochloride by RP-HPLC Method. Asian J. Research Chem. 2010; 3(4): 1069-1072. DOI: 10.5958/0974-4150
19. Patel MD., Dedania Z. Development and Validation of UV Method for Simultaneous Estimation of Bilastine and Montelukast in Combined Pharmaceutical dosage form. Int. J. Res. Ana. Reviews (IJRAR). 2021; 8(3):1-14.
20. Patel MD., Dedania Z, Dedania R. RP-HPLC Method Development and Validation for Bilastine and Montelukast in Combined Pharmaceutical Dosage Form. Journal of Xi'an University of Architecture and Technology. 2021; 13 (7):751-8.
21. Zarna Dedania, Ronak Dedania, G Vidhyasagar, Bhavna Patel, Chetan Ramolia, Vaishali Karkhanis. Development and Validation of HPTLC Method for Simultaneous Estimation of Omeprazole and Ondansetron in Tablet Dosage Form. Asian J. Research Chem. 2009; 2(4): 574-576.
22. Bhavna Patel, Zarna Dedania, Ronak Dedania, Chetan Ramolia, G Vidya Sagar, Mehta RS. Simultaneous Estimation of Lansoprazole and Domperidone in Combined Dosage Form by RP-HPLC. Asian J. Research Chem. 2009; 2(2): 210-212.
23. Zarna Dedania, Ronak Dedania, Vaishali Karkhanis, G Vidya Sagar, Meeta Baldania, NR Sheth. RP-HPLC Method for Simultaneous Estimation of Omeprazole and Ondansetron in Combined Dosage Forms. Asian J. Research Chem. 2009; 2(2): 108-111.
24. Chetan Ramolia, Zarna Dedania, Ronak Dedania, Sheth NR, G Vidya sagar, Bhavna Patel, Bhatt KK. Simultaneous Estimation of Metformin Hydrochloride, Rosiglitazone Maleate and Glimepiride in Pharmaceutical Dosage Forms by RP-HPLC Method. Asian J. Research Chem. 2010; 3(1): 83-86.