Drug Res (Stuttg) 2020; 70(12): 552-562
DOI: 10.1055/a-1167-0529
Original Article

Development and Validation of a Stability Indicating LC-MS/MS Method for the Determination of Clenbuterol HCl

Krunal J. Prajapati
1   Department of Pharmaceutical Analysis, Institute of Pharmacy, Nirma University, Ahmedabad, Gujarat, India
,
Charmy Kothari
1   Department of Pharmaceutical Analysis, Institute of Pharmacy, Nirma University, Ahmedabad, Gujarat, India
› Author Affiliations
Funding: This research did not receive any specific grant from funding agencies in the public, commercial, or not-for-profit sectors.

Abstract

Clenbuterol hydrochloride (CLT), β2 adrenergic agonist is used as a bronchodilator in the therapeutic treatment of asthma. It is important to know the stability behaviour of the drug in different degradation conditions as per ICH Q1A (R2) guidelines for safety and efficacy purpose. The main objective of the study is to develop and validate stability indicating LC-MS/MS method for the determination of Clenbuterol HCl. The separation was achieved using Phenomenex Gemini NX C18 (250*4.6 mm, 5 μ) column and the mobile phase consisting of ammonium acetate buffer (5 mM), 0.15% triethylamine (TEA), pH 7.5 with acetic acid: methanol (70:30, v/v) at flow rate 1 ml/min. The detection was done using PDA detector at 245 nm. The validation was performed as per ICH Q2 (R1) guideline. The drug was subjected to stress degradation conditions as per ICH Q1A (R2) guidelines. The significant degradation was observed in acidic (8.78%) and sunlight (liquid) (9%) condition while no degradation was observed in neutral, basic, oxidation and thermal condition. The drug and its degradation products were characterized using LC-MS/MS and the proposed degradation mechanism was communicated. The developed method was found to be stability-indicating, simple, specific, selective, sensitive, linear, accurate, robust and precise and used as a routine analysis in quality control laboratory.

Supporting Information



Publication History

Received: 16 March 2020

Accepted: 13 April 2020

Article published online:
16 September 2020

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