A validated stability indicating RP-HPLC method development and validation of for simultaneous estimation of indacaterol and glycopyrrolate in pharmaceutical dosage form

Authors

  • Vani Gajula Department of Pharmaceutical analysis, M.L.College of Pharmacy, S. Konda-523101.
  • Thejomoorthy K Head, Department of Pharmaceutical analysis, M.L.College of Pharmacy, S. Konda-523101.
  • Sreenivasa Prasanna P Principal, M.L.College of Pharmacy, S.Konda-523101

DOI:

https://doi.org/10.47957/ijpda.v9i2.464

Keywords:

Indacaterol, Glycopyrronium, RP-HPLC

Abstract

A simple, Accurate, precise method was developed for the simultaneous estimation of the Indacaterol and Glycopyrronium in the bulk and pharmaceutical dosage form. The chromatogram was run through Std Denali C18150 x 4.6 mm, 5m. Mobile phase containing Buffer 0.1%OPA: Acetonitrile taken in the ratio 55:45 was pumped through the column at a flow rate of 0.8 ml/min. The buffer used in this method was 0.1% OPA buffer. The temperature was maintained at 30°C. The optimized wavelength selected was 230.0 nm. The retention time of Indacaterol and Glycopyrronium were found to 2.323min and 3.140 %RSD of the Indacaterol and Glycopyrronium were %RSD found to be 0.2% and 0.2% respectively. %Recovery was obtained as 99.39% and 99.41% for Indacaterol and Glycopyrronium respectively. LOD, LOQ values obtained from regression equations of Indacaterol and Glycopyrronium were 1.08, 3.28, and 0.25, 1.47 respectively. Regression equation of Indacaterol is y = 24501x + 7142.3, y = 26335x + 7822.7of Glycopyrronium.Retention times were decreased and run time was decreased, so the method developed was simple and economical that can be adopted in regular Quality control tests in Industries.

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References

O’Neil MJ. The Merck Index an encyclopedia of Chemicals; Drugs and Biologicals. 14th ed. Merck &Co.Inc; 2006. p. 4244.

Bhaskar VH., Amirthalingam S. Clinical Pharmacy. 1st ed. Nirav Prakashan publishers; 2013. p. 61.

“Glycopyrrolate” March 2016, https://www.drugs.com/cdi/glycopyrrola te.html. Updated On March 2106.

http://www.nps.org.au/publications/heal th-professional/nps-radar/2014/april2014. Updated On 1 April 2014.

http://www.vectura.com/news/ultibrobreezhaler-qva149-app. Updated on October 2016.

Salem YA, Sherbiny DT, Wasseef DR, Ashry SM. Spectroscopic study on Indacaterol maleate: Analytical applications for quality control of capsules. International J Pharm Sci Res 2015; 6(3): 592-605.

Salem YA ,Sherbiny DT, Wasseef DR, Ashry SM. HPLC Determination of Indacaterol Maleate in Pharmaceutical Preparations Adopting Ultraviolet and Fluorescence Detection.International J Pharm Sci Res 2015; 6(2): 1324-1332.

Wesam GA, Al-Qadhi Z, Mohammad K, Rabab T, Qammaz S, Oriquat G, Basheti IA, Chrystyn H. A Validated Liquid Chromatography-Tandem Mass Spectrometry Coupled with LiquidLiquid Extraction for Indacaterol Quantitation in Human Plasma. Advance Pharmacol Pharm 2015; 3(2): 43-51.

Gandala K, Pabba P, Akula G. RPHPLC method development and validation for estimation of glycopyrrolate in bulk and tablet dosage forms Asian J Pharm Clin Res 2011; 4(4): 37-40.

Venketshwaran TG, King DT, Stewart JT. HPLC determination of oldansetronatropine and oldansetron-glycopyrrolate mixtures in 0.9% sodium chloride injection.Journalliqchrom 2006; 18(13): 2647-2659.

United State Pharmacopoeia USP30, NF 25, US Pharmacopoeial Convention INC.; Rockville; 2007. p. 2242-2742.

British Pharmacopoeia, Vol 2 & 3. Her Majesty’s Stationary Office: London; 2013. p. 334.

ICH, Q2 (R1), Harmonized tripartite guideline, Validation of analytical procedures: text and methodology, International Conference on Harmonization ICH, Geneva, Nov 2005.

Rao CP, Rahaman SA, Prasad YR, Reddy PG. RP-HPLC method of simultaneous estimation of amlodipine besylate and metoprolol in combined dosage form. International Journal of Pharmaceutical Research and Development. 2010 Nov;2(9):69-76.

Rao CM, Konda R, Ramanjeneeyulu S. Estimation of Nevirapine Anhydrous Bulk Formulation by Using IR, RP-HPLC, GC Methods. Research Journal of Pharmacy and Technology. 2010 Dec 28;3(4):1088-92.

Ch M MPrasada et al, Development and Validation of a Novel Stability Indicating RP-HPLC Method for The Estimation of Entecavir In Tablet Formulation, EJBPS, 2017, 4(7):176-180.

Lavina Rajawat, Jigna T Patel, Chirag J Patel, and M. M. Patel. “RP-HPLC Method Development And Validation Of Tetrabenazine With Its Known And Unknown Degra-Dation Impurities In Its Tablet Dosage Form”. International Journal of Pharmaceutics and Drug Analysis, Apr. 2018, pp. 453-6, https://www.ijpda.com/index.php/journal/article/view/390.

RowthulaPrasanna Surya Bhavani, R. P. S. B., and M. M. M.Sandhya Maduri. “STABILITY INDICATING METHOD DEVELOPMENT AND VALIDATION FOR THE SIMULTANEOUS ESTIMATION OF LEDIPASVIR AND SOFOSBUVIR IN BULK DRUG BY USING RP-HPLC”. World Journal of Current Medical and Pharmaceutical Research, Nov. 2020, pp. 307-18, doi:10.37022/wjcmpr.vi.159.

Published

2021-07-06
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How to Cite

Gajula , V., T. K, and S. P. P. “A Validated Stability Indicating RP-HPLC Method Development and Validation of for Simultaneous Estimation of Indacaterol and Glycopyrrolate in Pharmaceutical Dosage Form”. International Journal of Pharmaceutics and Drug Analysis, vol. 9, no. 2, July 2021, pp. 71-79, doi:10.47957/ijpda.v9i2.464.

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