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  • Method Development and Validation of Indacaterol Maleate By RP HPLC In Bulk and Pharmaceutical Dosage Form
  • 1Department of Pharmaceutical Quality Assurance, PRES College of Pharmacy (Women’s), Chincholi, Nashik422102
    2Department of Pharmaceutical Chemistry, PRES College of Pharmacy (Women’s), Chincholi, Nashik-422102

Abstract

A simple, sensitive and accurate RP-HPLC method has been developed for the determination of Indacaterol maleate in bulk and marketed formulation. The ?max of the Indacaterol maleate was found to be 260 nm in Methanol: water (90:10) pH 3.0. The method shows high sensitivity with linearity 10 to 50µg/ml (regression equation: y = 38835x + 278291; r2 = 0.9993). The various parameters according to ICH guidelines and USP are followed for validating and testing of this method. The Detection limit and quantitation limit were found to be 0.146 µg ml –1 and 0.442 µg ml–1 respectively. The results demonstrated that the procedure is accurate, specific and reproducible (RSD <2%), and also being simple, cheap and less time consuming and appropriate for the determination of Indacaterol maleate in bulk and Table dosage form.

Keywords

Indacaterol maleate, HPLC method, Method development, Validation

Reference

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Manali Katkade
Corresponding author

Department of Pharmaceutical Quality Assurance, PRES College of Pharmacy (Women’s), Chincholi, Nashik422102

image
Anagha Baviskar
Co-author

Department of Pharmaceutical Quality Assurance, PRES College of Pharmacy (Women’s), Chincholi, Nashik422102

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Kiran Kotade
Co-author

Department of Pharmaceutical Quality Assurance, PRES College of Pharmacy (Women’s), Chincholi, Nashik422102

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Charushila Bhangale
Co-author

Department of Pharmaceutical Chemistry, PRES College of Pharmacy (Women’s), Chincholi, Nashik-422102

Manali Katkade*, Anagha Baviskar, Kiran Kotade, Charushila Bhangale, Method Development And Validation Of Indacaterol Maleate By Rp-Hplc In Bulk And Pharmaceutical Dosage Form, Int. J. in Pharm. Sci., 2023, Vol 1, Issue 3, 125-133. https://doi.org/10.5281/zenodo.7606967

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