Ultra high performance liquid chromatography tandem mass spectrometric detection in clinical analysis of simvastatin and atorvastatin

Nováková, Lucie; Vlčková, Hana; Šatı́nský, Dalibor; Sadílek, Petr; Solichová, Dagmar; Bláha, M.; Bláha, V.; Solich, Petr

doi:10.1016/j.jchromb.2009.05.052

Cited by 57 publications

(53 citation statements)

References 29 publications

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“…The optimization of conditioning and washing solution composition, pH for conditioning and washing step and elution solvent selection were described in details. The SPE procedure has also been used as sample preparation step for quantification of atorvastatin and simvastatin as well as their metabolites in serum from patients with end stage renal disease [83]. In order to obtain the satisfactory and repeatable extraction efficacy and to remove matrix effects, several different reversed-phase SPE sorbents have been tested.…”

Section: Sample Preparationmentioning

confidence: 99%

“…Briefly, MEPS is a miniaturization of conventional SPE, but it differs from commercial SPE by fact that packing is inserted directly into the syringe, not into a separate column. In addition, they have compared a previously described [83] SPE procedure for extraction of atorvastatin and its metabolites from human serum with newly developed MEPS approach. The results of samples treated by SPE and MEPS were compared by means of Student t-test.…”

Section: Sample Preparationmentioning

confidence: 99%

“…Generally, in the HPLC methods reversed-phase C18 chromatographic columns were used for analysis of statin drugs in biological fluids. The recently developed columns based on BEH particles technology were employed in several methods [83,86,87]. Only in one assay reversed-phase C8 chromatographic column was used [88].…”

Section: High Performance Liquid Chromatographymentioning

confidence: 99%

“…The length and diameter of columns differed fairly from 50 to 250 mm and from 2.0 to 4.6 mm, respectively. Although in most of the cases columns with particle size 5 μm were used, several authors preferred columns with smaller particles in order to obtain better peak shapes, resolution and thus shorter analysis time [72,82,83,86,87]. Analytical run times have been very variable, the shortest 2 min, the longest about 20 min.…”

Section: High Performance Liquid Chromatographymentioning

confidence: 99%

See 3 more Smart Citations

A Review of Current Trends and Advances in Analytical Methods for Determination of Statins: Chromatography and Capillary Electrophoresis

Nigović¹,

Mornar²,

Sertić³

2012

Chromatography - The Most Versatile Method of Chemical Analysis

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Section: Sample Preparationmentioning

confidence: 99%

Section: Sample Preparationmentioning

confidence: 99%

Section: High Performance Liquid Chromatographymentioning

confidence: 99%

Section: High Performance Liquid Chromatographymentioning

confidence: 99%

See 2 more Smart Citations

A Review of Current Trends and Advances in Analytical Methods for Determination of Statins: Chromatography and Capillary Electrophoresis

Nigović¹,

Mornar²,

Sertić³

2012

Chromatography - The Most Versatile Method of Chemical Analysis

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“…ATV-FX1 (4-(1b-4-floro-fenil)-6-hidroksi-6-isopropil-1a-fenil-6a-fenilkarbomoil-hekzahidro-1,2-dioksa-5a-aza-siklopropa(a)inden-3-il-3-(R)-hidroksibutirik asit) atorvastatinin alkali asetonitrilli çözeltisinin içine hidrojen peroksit ilavesiyle hazırlanmıştır. Güneş ışığında birkaç saat atorvastatinin sulu asetonitrilli çözeltisinin pH:8- ise atorvastatinin biyolojik sıvılarda miktar tayini için bir UPLC/MS metodu geliştirilmiştir (12 Literatürlerde atorvastatinin miktar tayini ve safsızlıkla-rının analizleri için kromatografik ayırım genellikle tampon çözeltilerinin kullanıldığı gradient bir metot kullanılarak sağlanmıştır. Bu çalışmada, diklofenak sodyum internal standart olarak kullanılarak isokratik bir ayırım ile atorvastatin kalsiyumun analizinin yapılması amaçlanmıştır.…”

Section: Introductionunclassified

A Validated HPLC Method for Analysis of Atorvastatin Calcium in Tablet Dosage Forms

Temir¹,

Kaymakçıoğlu²

2013

MUSBED

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Atorvastatin kalsiyumun valide edilmiş HPLC metodu ile tablet formundan analizi Amaç: Atorvastatin kandaki kolesterolü düşürmek için kullanılan statin olarak bilinen ilaç sınıfının bir üyesidir. Atorvastatinin miktar tayini ve safsızlık analizleri için literatürlerde genellikle HPLC ile kombine edilmiş UV veya kütle dedektör sisteminin kullanıldığı yöntemler yer almaktadır. Bu yöntemlerde genellikle kromatografik ayırımın gradient bir metot ve tampon sistemi içeren bir mobil faz kullanılarak sağlandığı göze çarpmaktadır. Bu çalışmada atorvastatinin miktar tayini için diklofenak sodyumun internal standard olarak kullanıldığı ters faz sıvı kromatografisinde isokrotik bir metot geliştirilmiştir. Yöntem: Ters faz yüksek performanslı sıvı kromatografisi kullanılarak asetonitril ve % 0.01 ortofosforik asit (67:33 h/h) mobil fazı ile C 18 kolonda isokrotik bir ayırım gerçekleştirilmiştir. Bulgular: Atorvastatine ait alıkonma zamanı 3.770±0.200 dakika, internal standart olan diklofenaka ait alıkonma zamanı 5.266±0.200 dakikadır. Basit bir mobil faz kullanılarak metot optimize edilmiş; doğrusallık, kesinlik, doğruluk ve LOD-LOQ validasyon parametreleri açısından valide edilmiştir. Sonuç: Geliştirilen bu basit, hassas, duyarlı ve kesin yöntem atorvastatin kalsiyum için rutin analizlerde kullanılabilir. Anahtar sözcükler: Atorvastatin kalsiyum, tablet, HPLC, validasyon ABS TRACTA validated HPLC method for analysis of atorvastatin calcium in tablet dosage forms Objective: Atorvastatin is a member of the drug class known as statins, used for lowering blood cholesterol. Literature for the assay and impurity analysis of atorvastatin is usually combined with HPLC methods using UV or mass detection system. These methods are usually a gradient chromatographic separation method and a mobile phase containing buffer system using the provided stand out. In this study, an isocratic method was developed for which diclofenac sodium is used as internal standard for the determination of atorvastatin. Method: The separation was carried out on C 18 column using acetonitril and orthophosphoric acid (0.01%) (67:33 v/v) with isocratic separation using reversed phase high performance liquid chromatography. Results: The retention times of atorvastatin calcium is 3.770±0.200 min and internal standard diclofenac sodium is 5.266±0.200 min. The method was optimized using a simple mobile phase; validation parameters such as linearity, accuracy, precision and LOD-LOQ were validated in terms. . Conclusion:The developed method is simple, sensitive and precise. The developed method can be used as a routine analysis for atorvastatin calcium.

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Simultaneous determination of atorvastatin and niacin in human plasma by LC‐MS/MS and its application to a human pharmacokinetic study

Ravi¹,

Mullangi

Inamadugu³

et al. 2012

Biomedical Chromatography

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A rapid, simple, sensitive and selective LC-MS/MS method has been developed and validated for quantification of the atorvastatin (AT) and niacin (NA) in 250 μL human plasma. The analytical procedure involves a liquid-liquid extraction method using nevirapine as an internal standard (IS). The chromatographic separation was achieved on a Hypurity Advance (4.6 × 50 mm, 5 µm) column using a mobile phase consisting of 0.1% formic acid buffer-acetonitrile (20:80, v/v) at flow rate of 0.8 mL/min. The API-4000 LC-MS/MS was operated in the multiple-reaction monitoring mode using electrospray ionization. The total run time of analysis was 3 min and elution of AT, NA and IS occurred at 1.06, 1.84 and 0.92 min, respectively. A detailed validation of the method was performed as per the US Food and Drug Administration guidelines and the standard curves found to be linear in the range of 0.10-30.0 ng/mL for AT and 20.2-6026 ng/mL for NA, with a coefficient of correlation of ≥ 0.99 for both the compounds. AT and NA were found to be stable in a battery of stability studies, viz. bench-top, autosampler, re-injection, wet-extract and repeated freeze-thaw cycles. The developed assay method was successfully applied to a pharmacokinetic study in humans.

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Ultra high performance liquid chromatography tandem mass spectrometric detection in clinical analysis of simvastatin and atorvastatin

Cited by 57 publications

References 29 publications

A Review of Current Trends and Advances in Analytical Methods for Determination of Statins: Chromatography and Capillary Electrophoresis

A Review of Current Trends and Advances in Analytical Methods for Determination of Statins: Chromatography and Capillary Electrophoresis

A Validated HPLC Method for Analysis of Atorvastatin Calcium in Tablet Dosage Forms

Simultaneous determination of atorvastatin and niacin in human plasma by LC‐MS/MS and its application to a human pharmacokinetic study

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