scholarly journals A Stability-Indicating Ultra-Performance Liquid Chromatographic Method for Estimation of Related Substances and Degradants in Paliperidone Active Pharmaceutical Ingredient and its Pharmaceutical Dosage Forms

2012 ◽  
Vol 50 (4) ◽  
pp. 368-372 ◽  
Author(s):  
K. H. Bindu ◽  
I. U. Reddy ◽  
Y. Anjaneyulu ◽  
M. V. Suryanarayana
Keyword(s):  
Chromatographic Method ◽  
Active Pharmaceutical Ingredient ◽  
Dosage Forms ◽  
Pharmaceutical Dosage Forms ◽  
Stability Indicating ◽  
Related Substances ◽  
Liquid Chromatographic Method ◽  
Liquid Chromatographic

scholarly journals Development of a Stability-Indicating High-Performance Liquid Chromatographic Method for the Simultaneous Determination of Alprazolam and Sertraline in Combined Dosage Forms

2008 ◽  
Vol 91 (6) ◽  
pp. 1344-1353 ◽  
Author(s):  
Ashutosh Pathak ◽  
Sadhana J Rajput
Keyword(s):  
High Performance ◽  
Chromatographic Method ◽  
Degradation Products ◽  
High Performance Liquid Chromatographic ◽  
Reversed Phase ◽  
Dosage Forms ◽  
Dihydrogen Phosphate ◽  
Stability Indicating ◽  
Liquid Chromatographic Method ◽  
Liquid Chromatographic

Abstract The objective of the current study was to develop a validated stability-indicating high-performance liquid chromatographic method for alprazolam and sertraline in combined dosage forms. The method was validated by subjecting the drugs to forced decomposition under hydrolysis, oxidation, photolysis, and thermal stress conditions prescribed by the International Conference on Harmonization. The drugs were successfully separated from major and minor degradation products on a reversed-phase C18 column by using 75 mM potassium dihydrogen phosphate buffer (pH 4.3)acetonitrilemethanol (50 45 5, v/v/v) as the mobile phase with determination at 227 nm. The flow rate was 0.9 mL/min. The method was validated with respect to linearity, precision, accuracy, system suitability, and robustness. The responses were linear over the ranges of 180 and 5200 g/mL for alprazolam and sertraline, respectively. The recoveries of both drugs from a mixture of degradation products were in the range of 97101. The utility of the procedure was verified by its application to marketed formulations that were subjected to accelerated stability studies. The method distinctly separated the drugs and degradation products, even in actual samples. The products formed in marketed tablets were similar to those formed during stress studies.

Development and Validation of a Stability-Indicating High-Performance Liquid Chromatographic Method for the Quantification of Methocarbamol and Its Impurities in Pharmaceutical Dosage Forms

2021 ◽  
Author(s):  
Shivani Kalokhe ◽  
Santaji Nalwade ◽  
Pallavi Patil ◽  
Poonam Raskar
Keyword(s):  
High Performance ◽  
Chromatographic Method ◽  
High Performance Liquid Chromatographic ◽  
Dihydrogen Phosphate ◽  
Pharmaceutical Dosage Forms ◽  
Stability Indicating ◽  
Liquid Chromatographic Method ◽  
Validation Parameters ◽  
Limit Of Quantitation ◽  
Liquid Chromatographic

Abstract A novel, delicate, stability-indicating, gradient, reversed-phase high-performance liquid chromatographic method has been established for the quantitative estimation of methocarbamol (MTC) and its impurities present in a pharmaceutical oral suspension. XBridge C18, 5 μm, 250 mm × 4.6 mm column was used to accomplish chromatographic separation with a buffered mobile phase consisting of a mixture of 0.01 M of sodium dihydrogen phosphate (pH 7.0 buffer) and methanol in the ratio of 95:05 (v/v), respectively, were used as solvent A and a mixture of methanol and Milli-Q water in the ratio 90:10 (v/v), respectively, was used as solvent B. Analysis was carried out at 0.8 mL/min flow rate and the detection wavelength at 225 nm. The compartment temperature of the column is put at 25°C. The resolution of MTC and its four impurities has been attained >2.0 for all pairs of compounds. Significant degradation of MTC was photolytic, thermal and oxidative stress conditions. Validation of the developed method was performed as stated by the International Conference on Harmonization guidelines with regard to all validation parameters like specificity, accuracy, linearity, precision, limit of detection, limit of quantitation and robustness.

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