scholarly journals STABILITY INDICATING HPLC METHOD FOR THE DETERMINATION OF AGOMELATINE INPLASMA AND TABLET FORMULATION

2012 ◽  
Vol 45 (1) ◽  
pp. 535-548
Author(s):  
Hamed Abuseada
Keyword(s):  
Hplc Method ◽  
Tablet Formulation ◽  
Stability Indicating

RP-HPLC METHOD FOR DETERMINATION OF TOLPERISONE HYDROCHLORIDE IN TABLET FORMULATION

INDIAN DRUGS ◽  
2016 ◽  
Vol 53 (10) ◽  
pp. 48-53
Author(s):  
S. P Padmane ◽  
◽  
A. A Thakur ◽  
R. N. Alaspure ◽  
M. R. Tajne
Keyword(s):  
Oxidative Stress ◽  
Degradation Products ◽  
Hplc Method ◽  
Tablet Formulation ◽  
Stress Conditions ◽  
Stability Indicating ◽  
Rp Hplc ◽  
Effluent Flow Rate ◽  
And Oxidative Stress

The study describes a validated stability indicating reverse-phase HPLC method for the estimation of tolperisone in bulk and in tablet formulation. The proposed RP-HPLC method utilizes a Hypersil C18 column (250 × 4.6 mm, 5 μm), optimum mobile phase consisted of methanol: acetonitrile: water (containing triethylamine 1% V/V) in the ratio of (85:10:5 V/V/V), effluent flow rate was kept at 1.0 mL/min and UV detection wavelength 250 nm. Tolperisone was exposed to various hydrolytic, thermal, photolytic and oxidative stress conditions, and the stressed samples were analysed by proposed method. The drug showed degradation under alkali and neutral hydrolysis and oxidative stress conditions. The degradation products were well resolved from the drug and demonstrated that the method is specific stability indicating for assay of tolperisone in presence of degradation products. The developed method was validated for linearity, accuracy, precision, robustness, ruggedness and specificity.

scholarly journals New stability indicating RP-HPLC-PDA method for determination of mifepristone in bulk and tablet formulation

2021 ◽  
Vol 7 (1) ◽  
Author(s):  
Mohammad Mojeeb Gulzar Khan ◽  
Mohammad Faizan Saadique Deshmukh ◽  
Sandip Dinkar Firke ◽  
Abdul Talib Abdul Wahab ◽  
Mohan Ganpatrao Kalaskar ◽  
...  
Keyword(s):  
Mobile Phase ◽  
Hplc Method ◽  
Tablet Formulation ◽  
Forced Degradation ◽  
Established Method ◽  
Potassium Dihydrogen ◽  
Stability Indicating ◽  
Quantitation Limit ◽  
Rp Hplc

Abstract Background Mifepristone is progestational and glucocorticoid hormone antagonist. The objective of this study is to develop simple and economical stability indicating RP-HPLC method for the determination of mifepristone in bulk and tablet formulation. Result The chromatographic separation was achieved on Qualisil BDS C8 column with mobile phase containing of mixture of Buffer (Potassium dihydrogen ortho phosphate, pH to 3.0 with ortho phosphoric acid) and Organic Solvent (Acetonitrile) 60:40 v/v pumped at flow rate 0.6 mL min−1. The detection of elute was performed using PDA detector at 305 nm. Mifepristone was eluted at 8.67 min. According to international conference on harmonization Q2(R1) guideline, method was validated and shows satisfactory results for accuracy, precision, linearity, ruggedness, robustness, detection limit, quantitation limit. The method indicated to be linear in the series of concentration 3–18 µg mL−1, and correlation coefficient was 0.9997. In acidic, basic, oxidative, thermal, photolytic forced degradation conditions, the peak of degradation product was clearly and well separated from drug peak without any interference in quantitative analysis. This represents stability indicating nature of established method. Conclusion The established RP-HPLC method is simple, accurate, specific, precise, robust, rugged, sensitive, and economical in nature which can be utilized for routine analysis of mifepristone in bulk and pharmaceutical formulation.

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.

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