Development and Validation of RP-HPLC Method for Simultaneous Estimation of Bilastine and Montelukast in Combined Dosage Form
Corresponding Author(s) : Anjali Bardwaj
suralabs.publications@gmail.com
International Journal of Allied Medical Sciences and Clinical Research,
Vol. 10 No. 4 (2022): 2022 Volume -10 - Issue 4
Abstract
A rapid and precise reverse phase high performance liquid chromatographic method has been developed for the validated of Montelukast and Bilastine, in its pure form as well as in tablet dosage form. Chromatography was carried out on a Zorbax C18 (4.6 x 150mm, 5µm) column using a mixture of Methanol: Phosphate Buffer pH 3.9 (55:45v/v) as the mobile phase at a flow rate of 1.0ml/min, the detection was carried out at 255nm. The retention time of the Montelukast and Bilastine was 2.061, 2.462 ±0.02min respectively. The method produce linear responses in the concentration range of 1-5µg/ml of Montelukast and 100-500µg/ml of Bilastine. The method precision for the determination of assay was below 2.0%RSD. The method is useful in the quality control of bulk and pharmaceutical formulations.
Keywords
Montelukast, Bilastine, RP-HPLC, validation.
1.
Abdul Basith, Anjali Bardwaj, RamyaSri. S. Development and Validation of RP-HPLC Method for Simultaneous Estimation of Bilastine and Montelukast in Combined Dosage Form. Int. J. of Allied Med. Sci. and Clin. Res. [Internet]. 2022 Oct. 28 [cited 2025 Nov. 18];10(4):388-96. Available from: https://ijamscr.com/ijamscr/article/view/1257
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References
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1. Shethi PD. HPLC- quantitative analysis of pharmaceutical formulations. 1st ed. New Delhi: CBS Publishers & Distributors; 2001. p. 8-10, 101-3.
2. Kasture AV, Mahadik KR, Wadodkar SG, More HN. Pune: Nirali Prakashan. J Pharm Anal. 8th ed. 2002;II:48-57.
3. Prajapati GA. Method development and validation for simultaneous estimation of Hypertensive drugs by RP-HPLC [M.Pharm thesis]. Gujarat, India: Maliba Pharmacy College, Gujarat Technological University. p. 7-28; 2011.
4. Gabor S. HPLC in pharmaceutical Analysis. 1st ed. Vol. I. London: CRC Press; 1990. p. 101-73.
5. Jeffery GH, Bassett J. Vogel’s textbook of Quantitative Chemical Analysis. 5th ed. NY: John Wiley & Sons, Inc; 1991. p. 217-35.
6. Hobart HW, Merritt LL, John AD. Instrumental methods of analysis. 7th ed. New Delhi: CBS Publishers; 1988. p. 580-610.
7. Sharma BK. Instrumental method of chemical analysis. 20th ed. Meerut: Goel Publishing House; 2001. p. 54-83.
8. Ashutoshkar. Pharmaceutical drug analysis. 2nd ed. New Delhi. New Age International Publisher; 2005. p. 455-66.
9. Ahuja S, Michael WD. Hand book of Pharmaceutical Analysis by HPLC. 1st ed. London: Elsevier Academic Press; 2005. p. 44-54.
10. Snyder LR, Kirkland JL, Glajch JL. Practical HPLC method development. 3rd ed. New York: Wiley; 1988. p. 227.
11. Skoog DA, West DM. Principles of instrumental analysis. Saunders Golden Sunburst Series. 2nd ed. Philadelphia; 1980. p. 674-5, 690-6.
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2. Kasture AV, Mahadik KR, Wadodkar SG, More HN. Pune: Nirali Prakashan. J Pharm Anal. 8th ed. 2002;II:48-57.
3. Prajapati GA. Method development and validation for simultaneous estimation of Hypertensive drugs by RP-HPLC [M.Pharm thesis]. Gujarat, India: Maliba Pharmacy College, Gujarat Technological University. p. 7-28; 2011.
4. Gabor S. HPLC in pharmaceutical Analysis. 1st ed. Vol. I. London: CRC Press; 1990. p. 101-73.
5. Jeffery GH, Bassett J. Vogel’s textbook of Quantitative Chemical Analysis. 5th ed. NY: John Wiley & Sons, Inc; 1991. p. 217-35.
6. Hobart HW, Merritt LL, John AD. Instrumental methods of analysis. 7th ed. New Delhi: CBS Publishers; 1988. p. 580-610.
7. Sharma BK. Instrumental method of chemical analysis. 20th ed. Meerut: Goel Publishing House; 2001. p. 54-83.
8. Ashutoshkar. Pharmaceutical drug analysis. 2nd ed. New Delhi. New Age International Publisher; 2005. p. 455-66.
9. Ahuja S, Michael WD. Hand book of Pharmaceutical Analysis by HPLC. 1st ed. London: Elsevier Academic Press; 2005. p. 44-54.
10. Snyder LR, Kirkland JL, Glajch JL. Practical HPLC method development. 3rd ed. New York: Wiley; 1988. p. 227.
11. Skoog DA, West DM. Principles of instrumental analysis. Saunders Golden Sunburst Series. 2nd ed. Philadelphia; 1980. p. 674-5, 690-6.
12. Dr. Kealey, Haines PJ. Analytical chemistry. 1st ed. Bios Publisher; 2002. P. 1-7.
13. BraithWait A, Smith FJ. Chromatographic methods. 5th ed. Kluwer Academic Publishers; 1996. P. 1-2.
14. Weston A, Phyllisr. Brown, HPLC principle and practice. 1st ed. Academic press; 1997. P. 24-37.
15. Kazakevich Y, Lobrutto R. HPLC for pharmaceutical scientists. 1st ed. Wiley Interscience A JohnWiley & Sons, Inc Publishing House; 2007. P. 15-23.
16. Chromatography [online]. Wikipedia. Available from: http://en.wikipedia.org/wiki/Chromatography.