Author(s): Praful Sahare, Amit Nayak, Alok Pal Jain, Harikishor Barange

Email(s): praphul.222@gmail.com

DOI: 10.5958/2231-5675.2021.00006.5   

Address: Praful Sahare*, Dr. Amit Nayak, Dr. Alok Pal Jain, Harikishor Barange
RKDF College of Pharmacy, SRK University, Bhopal- 462026 Madhya Pradesh, India.
*Corresponding Author

Published In:   Volume - 11,      Issue - 1,     Year - 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.


Cite this article:
Praful Sahare, Amit Nayak, Alok Pal Jain, Harikishor Barange. Development of Validated Analytical Methods and Stability Indicating studies for Pharmaceutical Formulation. Asian J. Pharm. Ana. 2021; 11(1):29-37. doi: 10.5958/2231-5675.2021.00006.5

Cite(Electronic):
Praful Sahare, Amit Nayak, Alok Pal Jain, Harikishor Barange. Development of Validated Analytical Methods and Stability Indicating studies for Pharmaceutical Formulation. Asian J. Pharm. Ana. 2021; 11(1):29-37. doi: 10.5958/2231-5675.2021.00006.5   Available on: https://ajpaonline.com/AbstractView.aspx?PID=2021-11-1-6


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