An overview of the recent trends in development of HPLC methods for determination of impurities in drugs

Rao, R. Nageswara; Nagaraju, V.

doi:10.1016/s0731-7085(03)00293-0

Cited by 121 publications

(20 citation statements)

References 144 publications

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“…1,2 This indicates that the quality control of APIs should always be supported by additional purity profiling, based on the information obtained from the manufacturing process. Furthermore, the impurity profiling represents part of an analytical strategy used for combating falsification of medicines.…”

Section: Introductionmentioning

confidence: 99%

Impurity profiling of morphine by liquid chromatography-heated electrospray ionization mass spectrometry (LC-HESI-MS)

Petkovska¹,

Acevska²,

Chachorovska³

et al. 2017

Turk J Chem

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Separation of morphine and its impurities (related substances specified in relevant European Pharmacopoeia monographs, as well as the other naturally occurring coextracted alkaloids) was obtained within a close retention window on a reverse phase HPLC column, eluted with optimized gradient, consisting of methanol and 5 mM ammonium formate, adjusted to pH 10.2. Systematic optimization of the chromatographic conditions was carried out using design of experiments. According to their mass spectra, known and specified impurities were identified and tentative structures for unknown impurities were proposed. MS analyses were performed in positive ionization mode using heated electrospray ionization. Fragmentation patterns of the eluted compounds under optimized mass spectrometry conditions indicated that all detected impurities are structurally related to morphine.

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Section: Introductionmentioning

confidence: 99%

Impurity profiling of morphine by liquid chromatography-heated electrospray ionization mass spectrometry (LC-HESI-MS)

Petkovska¹,

Acevska²,

Chachorovska³

et al. 2017

Turk J Chem

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“…In order to follow the current good manufacturing practice of pharmaceuticals products, during the chemical synthesis of active ingredients, the possible impurities of reagents or starting materials have to be quantified to the lower limit based on the dosage of active ingredients [4,5,6]. The reported analytical method employs the quantification by ultra-performance liquid chromatography – electrospray ionisation mass spectrometry (UPLC-ESI-MS), high-performance liquid chromatography – ultra violet detector (HPLC-UV), capillary electrophoresis and high-performance liquid chromatography – evoprative light scattering detector (HPLC-ELSD) [5,6,7,8,9,10]. Some of the analytical methods reported for the determination of miglitol and its derivatives in the blood plasma have been previously described [11,12,13,14,15,16,17].…”

Section: Introductionmentioning

confidence: 99%

Development and Validation of Miglitol and Its Impurities by RP-HPLC and Characterization Using Mass Spectrometry Techniques

et al. 2016

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Alpha glucoside inhibitors used to treat type-2 diabetes mellitus (DM) are likely to be safe and effective. These agents are most effective for postprandial hyperglycemia. Miglitol is a type of drug used to treat type-2 DM. A simple, selective, linear, precise and accurate reversed-phase high-performance liquid chromatography (RP-HPLC) method was developed and validated for a related substance of miglitol and its identification, and characterization was done by different mass spectrometry techniques. The gradient method at a flow rate of 1.0 mL/min was employed on a prevail carbohydrate ES column (250 × 4.6 mm, 5 μm particle size) at a temperature of 35 °C. Mobile phase A consisted of 10 mM dipotassium hydrogen orthophosphate adjusted to pH 8.0 using concentrated phosphoric acid and mobile phase B consisted of acetonitrile. The ultraviolet detection wavelength was 210 nm and 20 μL of the sample were injected. The retention time for miglitol was about 24.0 min. Forced degradation of the miglitol sample was conducted in accordance with the International Conference on Harmonisation (ICH) guidelines. Acidic, basic, neutral, and oxidative hydrolysis, thermal stress, and photolytic degradation were used to assess the stability-indicating the power of the method. Substantial degradation was observed during oxidative hydrolysis. No degradation was observed under the other stress conditions. The method was optimized using samples generated by forced degradation and sample solutions spiked with impurities and epimers. Good resolution of the analyte peak from peaks, corresponding to process-related impurities, epimers and degradation products, was achieved and the method was validated as per the ICH guidelines. The method can successfully be applied for routine analysis of miglitol.

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“…Therefore, it is necessary to study the impurity profiles of drug substances to be used in the manufacturing process of drug products [10,11]. A few HPLC methods have appeared in the literature for the quantification of micafungin in plasma [12–16].…”

Section: Introductionmentioning

confidence: 99%

Development and Validation of a Stability-Indicating High Performance Liquid Chromatographic (HPLC) Method for the Determination of Related Substances of Micafungin Sodium in Drug Substances

Zhu

Luo

et al. 2013

IJMS

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An isocratic, sensitive and stability-indicating high performance liquid chromatographic (HPLC) method for separation and determination of the related substances of micafungin sodium was developed. The chromatographic separation was achieved on Agilent Zorbax SB-C18 column (250 × 4.6 mm, 5 μm). Forced degradation study confirmed that the newly developed method was specific and selective to the degradation products. The performance of the method was validated according to the present ICH guidelines for specificity, linearity, accuracy, precision and robustness. Regression analysis showed correlation coefficient value greater than 0.999 for micafungin sodium and its six impurities. Limit of detection of impurities was in the range of 0.006%–0.013% indicating the high sensitivity of the newly developed method. Accuracy of the method was established based on the recovery obtained between 98.2% and 102.0% for all impurities. RSD obtained for the repeatability and intermediate precision experiments, was less than 1.0%. The method was successfully applied to quantify related substances of micafungin sodium in bulk drugs.

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An overview of the recent trends in development of HPLC methods for determination of impurities in drugs

Cited by 121 publications

References 144 publications

Impurity profiling of morphine by liquid chromatography-heated electrospray ionization mass spectrometry (LC-HESI-MS)

Impurity profiling of morphine by liquid chromatography-heated electrospray ionization mass spectrometry (LC-HESI-MS)

Development and Validation of Miglitol and Its Impurities by RP-HPLC and Characterization Using Mass Spectrometry Techniques

Development and Validation of a Stability-Indicating High Performance Liquid Chromatographic (HPLC) Method for the Determination of Related Substances of Micafungin Sodium in Drug Substances

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