scholarly journals Development and validation of stability indicating rp-uplc assay method for the determination of lacosamide and quetiapine fumarate in bulk and tablet dosage forms

2019 ◽  
Vol 57 (2) ◽  
pp. 157-166
Author(s):  
Tene Sivaganesh ◽  
T. Rao ◽  
K. Ramasrinivas ◽  
U. SeshamRaju ◽  
Y. Shasikiran ◽  
...  
2012 ◽  
Vol 9 (4) ◽  
pp. 2023-2028 ◽  
Author(s):  
S. P. Gandhi ◽  
M. G. Dewani ◽  
T. C. Borole ◽  
M. C. Damle

Diacerein is a drug for osteoarthritis and is di-acetylated derivative of rein. Aceclofenac is used as an effective non-steroidal anti-inflammatory drug (NSAID) with anti-inflammatory, analgesic, and antipyretic properties. The present study describes degradation of diacerein and aceclofenac under ICH prescribed stress conditions (hydrolysis, oxidation, dry heat, wet heat, and photolysis) and establishment of a stability-indicating HPTLC assay method. Different degradation peaks were observed for diacerein when it was exposed to alkaline, and acid catalysed hydrolysis. For aceclofenac, decrease in peak area was observed with single peak of degradation product after oxidation. For HPTLC, RP-18 F254spre-coated plates, and mobile phase consisting of methanol: water 7: 3 v/v was used to achieve separation. Quantitation was done at 268 nm. The method was validated as per ICH Q2 R1 guidelines and results were in limit. The method was found to be simple, specific, precise, and stability indicating.


2021 ◽  
Vol 7 (1) ◽  
Author(s):  
J. Saroja ◽  
Anantha Lakshmi P.V. ◽  
Y. Rammohan ◽  
D. Divya Reddy

Abstract Background We describe a “stability-indicating liquid chromatography” technique for the estimation of dimethicone (DEC) and dicyclomine hydrochloride (DEH) in the established tablet formulations. Individual quantification of DEH and DEC was reported. But simultaneous quantification of DEH and DEC was lacking. DEH and DEC were analysed on an “XTerra C18 column (250 mm × 4.6 mm, 5 μm)” with the mobile phase solvent run isocratically with 0.1M K2HPO4-acetonitrile (55:45, v/v) on a flow speed of 1.0 mL/min. Results The chromatographic run period for the DEC and DEH assay was 6.0 min with retention times of 2.134 and 2.865 min, respectively. The method was validated for accuracy (99.453 to 100.417% and 99.703 to 100.303% recovery values for DEH and DEC, respectively), precision (RSV value 0.135% for DEC and 0.171% for DEH), linearity (5–15 μg/mL for DEH and 20–60 μg/mL for DEC), selectivity (no hinderance from excipients) and specificity (no hinderance from degradants) recovery. Conclusion The developed stability-indicating liquid chromatography process was well applied to established tablet formulations.


2008 ◽  
Vol 68 (9-10) ◽  
pp. 837-841 ◽  
Author(s):  
Ch. B. V. Narasimha Raju ◽  
Gunanidhi Panda ◽  
G. Nageswara Rao

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