Development of Stability-Indicating Uplc Method for Determining Zolpidem Tartrate and Its Product Related Variants in Drug Substance and Drug Products

Murthy, M. Vishnu; Krishnaiah, Ch.; Kumar, Ramesh; Mukkanti, K.

doi:10.1080/10826076.2012.678027

Cited by 9 publications

(6 citation statements)

References 11 publications

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“…However, the analysis time of the new CE method is slightly faster (< 3 min compared to ~5–8 min) in the HPLC reports [4, 13–17] or compared to the GC report (~5.28 min) [18]. Although the sensitivity is inferior compared to the reported methods, it possesses adequate sensitivity for the analysis of the active ingredient in the formulations.…”

Section: Resultsmentioning

confidence: 99%

“…The sensitivity of the newly developed CE method is inferior when compared to the reported HPLC-UV methods [ 4 , 14 ], HPLC-fluorescence [ 15 ], or to LC-MS/MS [ 3 , 17 , 31 ] ( Table 2 ). However, the analysis time of the new CE method is slightly faster (< 3 min compared to ~5–8 min) in the HPLC reports [ 4 , 13 – 17 ] or compared to the GC report (~5.28 min) [ 18 ]. Although the sensitivity is inferior compared to the reported methods, it possesses adequate sensitivity for the analysis of the active ingredient in the formulations.…”

Section: Resultsmentioning

confidence: 99%

“…Several analytical methods for the determination of ZT have been reported in pharmaceutical formulations and plasma using high-performance liquid chromatography (HPLC) whether coupled with UV detection in in-process control synthesis samples [ 4 ], in rat serum [ 13 ], to be stability-indicating in pharmaceutical formulations [ 14 ], with fluorescence in human plasma samples [ 15 , 16 ], mass spectrometry in oral fluid liquid [ 3 ], in pharmaceutical formulation [ 17 ], or in hair [ 18 ]. Gas chromatography coupled with mass spectrometry (GC-MS) in postmortem specimens [ 19 ] and capillary electrophoresis (CE) coupled with fluorescence detection in urine [ 20 ] have also been reported.…”

Section: Introductionmentioning

confidence: 99%

“…These methods either use expensive mass spectrometers [ 17 , 21 , 22 ] or have a long separation time (4–8 min) [ 4 , 13 – 16 , 20 ] that is not suitable for the analysis of a large number of samples.…”

Section: Introductionmentioning

confidence: 99%

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Development and Validation of a Stability-Indicating Capillary Electrophoresis Method for the Determination of Zolpidem Tartrate in Tablet Dosage form with Positive Confirmation Using 2D and 3D-DAD Fingerprints

et al. 2014

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The aim of the current study was to develop a simple, precise, and accurate capillary zone electrophoresis method for the determination of zolpidem tartrate in tablet dosage form. Separation was conducted in normal polarity mode at 25°C, 22 kV, using hydrodynamic injection for 10 s. Separation was achieved using a background electrolyte of 20 mM disodium hydrogen phosphate adjusted with phosphoric acid (85%), pH at 5.50, and detection at 254 nm. Using the above optimized conditions, complete determination took place in less than 3 min using amiloride HCl as the internal standard. The method was linear over the range of 3–1000 μg mL−1 with a correlation coefficient of 0.9999. Forced degradation studies were conducted by introducing a sample of zolpidem tartrate standard and pharmaceutical sample solutions to different forced degradation conditions, being neutral (water), basic (0.1 M NaOH), acidic (0.1 M HCl), oxidative (10% H2O2), temperature (60°C in oven for 3 days), and photolytic (exposure to UV light at 254 nm for 2 h). Degradation products resulting from the stress studies did not interfere with the detection of zolpidem tartrate and the assay can be considered stability-indicating.

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Section: Resultsmentioning

confidence: 99%

Section: Resultsmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

See 2 more Smart Citations

Development and Validation of a Stability-Indicating Capillary Electrophoresis Method for the Determination of Zolpidem Tartrate in Tablet Dosage form with Positive Confirmation Using 2D and 3D-DAD Fingerprints

et al. 2014

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“…This study was performed to identify the molecule behavior during the different stress conditions [29][30][31][32][33]. The degradation impurities, process impurities, and unknown impurities were well resolved and determined.…”

Section: Forced Degradation Studymentioning

confidence: 99%

A simple high‐performance liquid chromatography method development for Carbidopa and Levodopa impurities: Evaluation of risk assessment before method validation by Quality by Design approach

Subramanian

Konduru

Katari

et al. 2020

Separation Science Plus

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The current study is to develop a simple high-performance liquid chromatography method for Carbidopa and Levodopa impurities' simultaneous determination with the combination of Entacapone in solid oral dosage forms. The estimation of impurities are critical in a combination product due to the more number of impurities. The presence of impurities in drug products affects quality and bio-efficacy. The quality by design approach allows the assessment of various analytical parameters and their effects with the minimum number of experiments. The current high-performance liquid chromatography method was developed using a kromasil column with gradient mobile phase. The detection was made 220 nm; the flow rate was 1.0 mL/min, and the column's temperature was 25 • C. The analytical curves presented a coefficient of correlation of >0.99, and detection and quantification limits were evaluated for all impurities. Excellent precision and accuracy were obtained for carbidopa and levodopa impurities. Intra-and interday precisions RSD were lower than 10.0, and recoveries of impurities varied between 91.2 and 108.2%. The results reveal the method's successful applicability for estimating Carbidopa and Levodopa with their process and degradation impurities from its marketed formulation.

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UPLC versus HPLC on Drug Analysis: Advantageous, Applications and Their Validation Parameters

2013

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Development of Stability-Indicating Uplc Method for Determining Zolpidem Tartrate and Its Product Related Variants in Drug Substance and Drug Products

Cited by 9 publications

References 11 publications

Development and Validation of a Stability-Indicating Capillary Electrophoresis Method for the Determination of Zolpidem Tartrate in Tablet Dosage form with Positive Confirmation Using 2D and 3D-DAD Fingerprints

Development and Validation of a Stability-Indicating Capillary Electrophoresis Method for the Determination of Zolpidem Tartrate in Tablet Dosage form with Positive Confirmation Using 2D and 3D-DAD Fingerprints

A simple high‐performance liquid chromatography method development for Carbidopa and Levodopa impurities: Evaluation of risk assessment before method validation by Quality by Design approach

UPLC versus HPLC on Drug Analysis: Advantageous, Applications and Their Validation Parameters

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