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Research Journal of Pharmacy and Technology
Year : 2020, Volume : 13, Issue : 6
First page : ( 2819) Last page : ( 2824)
Print ISSN : 0974-3618. Online ISSN : 0974-360X.
Article DOI : 10.5958/0974-360X.2020.00502.8

New validated stability indicating RP-UFLC method for the determination of Budesonide

Sheela Avuthu Sai, Annapurna Mukthinuthalapati Mathrusri*, Yasaswini Rangisetty Spandana

Department of Pharmaceutical Analysis, GITAM Institute of Pharmacy, GITAM (Deemed to be) University, Visakhapatnam-530045, India

*Corresponding Author E-mail: mmukthin@gitam.edu

Online published on 4 July, 2020.

Abstract

Budesonide is a glucocorticoid used in the long-term management of asthma and chronic obstructive pulmonary disease (COPD). Also used to prevent difficulty breathing, chest tightness, wheezing and coughing caused by asthma. A new stability indicating RP-UFLC method has been developed and validated for the determination of Budesonide in pure and pharmaceutical dosage forms. Shimadzu Model CBM-20A/20 Alite UFLC system (Shimadzu Co., Kyoto, Japan) equipped with SPD M20A prominence photodiode array detector on Agilent C18 column was used with a mobile phase consisting of formic acid and ACN (25: 75, v/v) and flow rate 1.2 ml/min (UV detection at 247 nm). Budesonide obeys Beer-Lambert's law over a concentration range of 10–100 μg/ml. The linear regression equation was found to be y = 35317x + 3515.8 (r2 = 0.9999). The LOD and LOQ was found to be and 2.913 and 8.7643 μg/ml. Budesonide was subjected to forced degradation and the method was validated as per ICH guidelines.

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