HPLC METHOD DEVELOPMENT AND VALIDATION OF SPIRONOLACTONE IN TABLET DOSAGE FORMS IN PRESENCE OF IMPURITIES AND DEGRADANTS
AbstractAn isocratic reversed-phase HPLC method was developed and validated to estimate and separate spironolactone and its related substances in its tablet dosage forms. Estimation and separation were achieved on Symmetry C-8 analytical column (150X3.9) mm, 5µm, using Water, Tetrahydrofuran (THF), and Acetonitrile (ACN) in the ratio of 77:21:2 v/v as mobile phase at the flow rate of 20 µl. UV photodiode array (UV PDA) detector detects the peaks at the wavelength of 254 and 283 nm. Validation studies were carried out for specificity, accuracy, precision, limit of detection (LOD), and quantitation (LOQ). Validation studies revealed that the method is simple, reliable and reproducible. The limit of detection and limit of quantitation for spironolactone, canrenone, and β-isomer was achieved 0.018% and 0.053%, 0.022% and 0.66% and 0.028%, and 0.084%, respectively. Forced degradation studies were carried out for stability testing, and system suit parameters were also performed to test the method.
Article Information
22
4991-5000
977 KB
480
English
IJPSR
Rini Singhal *, Chhaya Cauhan, Preeti Sharma and Monika Sachdeva
Raj Kumar Goel Institute of Technology, Ghaziabad, Uttar Pradesh, India.
rini.pharma20@gmail.com
06 April 2022
18 May 2022
03 June 2022
10.13040/IJPSR.0975-8232.13(12).4991-00
01 December 2022
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