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Asian Journal of Pharmaceutical Analysis
Year : 2021, Volume : 11, Issue : 1
First page : ( 29) Last page : ( 37)
Print ISSN : 2231-5667. Online ISSN : 2231-5675.
Article DOI : 10.5958/2231-5675.2021.00006.5

Development of validated analytical methods and stability indicating studies for pharmaceutical formulation

Sahare Praful*, Dr. Nayak Amit, Dr. Jain Alok Pal, Barange Harikishor

RKDF College of Pharmacy, SRK University, Bhopal-462026Madhya Pradesh, India

*Corresponding Author E-mail: praphul.222@gmail.com

Online published on 27 April, 2021.

Abstract

A simple, accurate rapid and precise has been developed and validated for estimation of Canagliflozin hemihydrate in Pharmaceutical Tablet Formulation by VU-Spectrophotometer and RP-HPLC Method. The successful estimation was carried out of the drug product is developed on the Jasco V-630 and Shimadzu-UV-1700 for VU-Spectrophotometer method and for HPLC successful estimation was carried out of the drug product is developed on the ACE Column C18 (150mm x 4.6mm, 5μm or equivalent) at ambient temperature using Acetonitrile: Orthophosphoric acid (1%) (60: 40 v/v) as mobile phase composition. The flow rate was adjusted to 1.0mL/minute and the absorption maxima were observed on UV detector at 290nm. Retention time for Canagliflozin hemihyd rate 3.0±0.5 min. The linearity was obtained in the concentration range of 80%-120% for Canagliflozin hemihydrate. For the HPLC method injection volume should be 20μL.The method was robust with respect to change in flow rate, temperature and composition of mobile phase. The method was validated statistically and applied successfully for the determination of Canagliflozin hemihydrate by VU-Spectrophotometer and RP-HPLC method. Validation studies revealed that method is specific, rapid, reliable, and reproducible. The high recovery and low relative standard deviation confirm the suitability of the method for the routine determination of Canagliflozin hemihydratein pharmaceutical cream formulation.

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Keywords

Canagliflozin Hemihydrate, Method Development, Method Validation, Stability Indicating Method Validation, Uv-Spetrophotometer, RP-HPLC, ICH Guideline.

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