A novel stability indicating HPLC method for the determination of enantiomeric purity of eluxadoline drug: Amylose tris (3, 5‐dichlorophenyl carbamate) stationary phase

2021 ◽  
Author(s):  
Sudhakar Yerra ◽  
Hemantkumar Sharma ◽  
B. Sreenivasulu ◽  
K. Mohana Naidu ◽  
B. Venkateswara Rao
Keyword(s):  
Stationary Phase ◽  
Hplc Method ◽  
Enantiomeric Purity ◽  
Stability Indicating

Chromatographic Separation of the Novel Hypoglycemic Drug Mitiglinide in its Bulk Powder and Pharmaceutical Formulation: Forced Degradation and Validated Stability-Indicating HPTLC/Densitometry and HPLC/UV Methods

2020 ◽  
Vol 103 (3) ◽  
pp. 736-742
Author(s):  
Maya S Eissa ◽  
Eman Darweish ◽  
Mohammed R Elghobashy ◽  
Mostafa A Shehata
Keyword(s):  
Stationary Phase ◽  
Flow Rate ◽  
Mobile Phase ◽  
Hplc Method ◽  
Forced Degradation ◽  
Stability Indicating ◽  
Relative Standard ◽  
Hypoglycemic Drug ◽  
Hptlc Method

Abstract Background Mitiglinide (MTG) is one of meglitinides group which are used for treatment of type two diabetes mellitus. Objective Mitiglinide (MTG) is a novel oral hypoglycemic drug. The present work adopts two stability-indicating chromatographic methods for determination of MTG after being exposed to forced degradation using 4 M methanolic HCl for 12 h. Methods The first method is HPTLC/densitometry using methanol:chloroform:acetic acid (5:2.5:0.3 by volume) as the eluting system and silica gel 60 GF254 as the stationary phase; the separated bands were then scanned at 220 nm. The second method is HPLC/UV in which acetonitrile:methanol:0.05 M potassium dihydrogen orthophosphate (pH 3.5) (40:25:35 by volume) was used as the mobile phase and a Zorbax SB-C8 (250 × 4.6 mm, 5 µm) column as a stationary phase, at a flow rate of 1 mL/min and UV detection at 220 nm. Results As a result of acid hydrolysis, two degradants were obtained. The first one was benzyl succinic acid to which this study was performed. The second one lacked configuration and was unreadable using UV spectrometry. Linearity was in the range of 8–48 µg/band MTG for HPTLC and 10–80 µg MTG for HPLC. LOD and LOQ values were 1.85 and 5.62 µg/band for the HPTLC method and 2.14 and 6.49 µg/mL for the HPLC method, respectively. The Recovery % was 100.03 ± 1.464 and 99.61 ± 1.44 using the HPTLC and HPLC methods, respectively. The relative standard deviations (RSD, %) for intra- and inter-day assays were 1.111 and 1.430 for the HPTLC method, respectively, and those for the HPLC method were 1.377 and 0.866, respectively. The RSD, %, for robustness testing was 1.162 (saturation time of mobile phase) and 1.592 (change in ratio of methanol content) for the HPTLC method and 1.377 (mobile phase composition), 1.713 (detector wavelength) and 1.770 (mobile phase flow rate) for the HPLC method. Conclusions The adopted methods were successfully applied for the determination of MTG in its pure form, in presence of its acid degradant and in its tablet dosage form. Highlights Statistical comparison between the results obtained from the developed methods and those obtained by the reported HPLC method showed no significance difference.

A Stability-indicating HPLC Method for the Simultaneous Determination of Mebeverine Hydrochloride and Chlordiazepoxide in Commercial Tablets

2013 ◽  
Vol 10 (4) ◽  
pp. 565-573 ◽  
Author(s):  
Hala Heneedak ◽  
Ismail Salama ◽  
Samia Mostafa ◽  
Mohamed El-Sadek
Keyword(s):  
Simultaneous Determination ◽  
Hplc Method ◽  
Stability Indicating ◽  
Mebeverine Hydrochloride

scholarly journals A new stability-indicating RP-HPLC method for the determination of dicyclomine hydrochloride and dimethicone combination in tablet dosage forms

2021 ◽  
Vol 7 (1) ◽  
Author(s):  
J. Saroja ◽  
Anantha Lakshmi P.V. ◽  
Y. Rammohan ◽  
D. Divya Reddy
Keyword(s):  
Liquid Chromatography ◽  
Dosage Forms ◽  
Flow Speed ◽  
Hplc Method ◽  
Stability Indicating ◽  
Simultaneous Quantification ◽  
Rp Hplc ◽  
Tablet Formulations ◽  
Tablet Dosage

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.

Validation of a Stability-Indicating HPLC Method for the Determination of Dipyridamole in Dipyridamole Injection

1997 ◽  
Vol 20 (13) ◽  
pp. 2109-2121 ◽  
Author(s):  
John Zhang ◽  
R. Brent Miller ◽  
Susan Russell ◽  
Robert Jacobus
Keyword(s):  
Hplc Method ◽  
Stability Indicating
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