scholarly journals Stability-Indicating Liquid Chromatographic Method for Determination of Saxagliptin and Structure Elucidation of the Major Degradation Products Using LC-MS

2014 ◽  
Vol 53 (4) ◽  
pp. 554-564 ◽  
Author(s):  
M. F. Abdel-Ghany ◽  
O. Abdel-Aziz ◽  
M. F. Ayad ◽  
M. M. Tadros
Keyword(s):  
Structure Elucidation ◽  
Chromatographic Method ◽  
Degradation Products ◽  
Stability Indicating ◽  
Liquid Chromatographic Method ◽  
Liquid Chromatographic

scholarly journals Determination of Cefdinir by a Stability-Indicating Liquid Chromatographic Method

2005 ◽  
Vol 88 (6) ◽  
pp. 1661-1665 ◽  
Author(s):  
Tushar N Mehta ◽  
Gunta Subbaiah ◽  
Kilambi Pundarikakshudu
Keyword(s):  
Chromatographic Method ◽  
Degradation Products ◽  
Reversed Phase ◽  
Stability Indicating ◽  
Pharmaceutical Ingredients ◽  
Degraded Samples ◽  
Liquid Chromatographic Method ◽  
Phase Liquid ◽  
Liquid Chromatographic

Abstract A simple, fast, specific, stability-indicating, and precise reversed-phase liquid chromatographic method was developed for the determination of Cefdinir in its different dosage forms, i.e., capsules and suspensions. The method was developed and optimized by analyzing the placebo preparation, formulations, and degraded samples of the drug substance according to the International Conference on Harmonization. The proposed method can successfully separate the drug from degradation products formed under stress conditions along with pharmaceutical ingredients such as preservatives. The developed method was used successfully to determine Cefdinir in capsules and Insta-use suspensions. The developed method was found to be linear for a concentration range of 6–14 μg/mL. Average recoveries obtained with the method were 99.3 ± 0.4 and 99.6 ± 0.4% for Insta-use suspensions and capsules, respectively. The method was shown to be specific, precise, and robust.

A Versatile Stability-indicating Liquid Chromatographic Method for the Simultaneous Determination of Atenolol, Hydrochlorothiazide and Chlorthalidone

2020 ◽  
Vol 16 (8) ◽  
pp. 1037-1051
Author(s):  
Ehab Farouk Elkady ◽  
Marwa Ahmed Fouad ◽  
Abdulgabar A. Ezzy Faquih
Keyword(s):  
Quality Control ◽  
Chromatographic Method ◽  
Degradation Products ◽  
Pharmaceutical Dosage Forms ◽  
Potassium Dihydrogen ◽  
Ich Guidelines ◽  
Liquid Chromatographic Method ◽  
Liquid Chromatographic ◽  
Potassium Dihydrogen Orthophosphate

Background: Atenolol is a selective beta 1 blocker that can be used alone or in combination with hydrochlorothiazide or with chlorthalidone for the treatment of hypertension and prevention from a heart attack. Objective: The main target of this work was to improve modern, easy, accurate and selective liquid chromatographic method (RP-HPLC) for the determination of these drugs in the presence of their degradation products. These methods can be used as analytical gadgets in quality control laboratories for a routine examination. Methods: In this method, the separation was accomplished through an Inertsil® ODS-3V C18 column (250 mm x 4.6 mm, 5 μm), the mobile phase used was 25 mM aqueous potassium dihydrogen orthophosphate solution adjusted to pH 6.8 by using 0.1M sodium hydroxide and acetonitrile (77 : 23, v/v), the flow rate used was 1 ml/min and detection was achieved at 235 nm using UV. Results: All peaks were sharp and well separated, the retention times were atenolol degradation (ATN Deg.) 2.311 min, atenolol (ATN) 2.580 min, hydrochlorothiazide degradation (HCT Deg.) 5.890 min, hydrochlorothiazide (HCT) 7.016 min, chlorthalidone degradation CTD Deg 8.018 min and chlorthalidone (CTD) 14.972 min. Linearity was obtained and the range of concentrations was 20- 160 μg/ml for atenolol, 10-80 μg/ml for hydrochlorothiazide and 10-80 μg/ml for chlorthalidone. According to ICH guidelines, method validation was accomplished, these methods include linearity, accuracy, selectivity, precision and robustness. Conclusion: The optimized method demonstrated to be specific, robust and accurate for the quality control of the cited drugs in pharmaceutical dosage forms.

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