A Simple HPLC Method for Simultaneous Determination of Lopinavir, Ritonavir and Efavirenz

Usami, Yoshiko; Oki, Tsuyoshi; Nakai, Masahiko; Sagisaka, Masafumi; Kaneda, Toshio

doi:10.1248/cpb.51.715

Cited by 49 publications

(21 citation statements)

References 6 publications

Supporting

Mentioning

Contrasting

Order By: Relevance

“…Several High Performance Liquid Chromatography (HPLC) methods have been described in the literature for the determination of lopinavir and ritonavir individually (Yekkala et al, 2008;Dias et al, 2005;Faux et al, 2001). These are for the determination of antiretrovirals simultaneously in human plasma by Reverse phase-HPLC: Wang et al (2006), Rentsch, (2003, Gangl et al (2002), and Usami et al, (2003) Two High performance liquid chromatography (HPLC) methods (Donato et al, 2006;USP, ) and one High performance thin layer chromatography (HPTLC) method (Sulebhavikar et al, 2008) were reported in the literature for determination of lopinavir and ritonavir in soft gelatin capsules and were fully validated as per International congress Harmonization (ICH) requirements. However, HPLC method reported by Donato et al (2006) was restricted to the determination of lopinavir and ritonavir only from its degradation products and the details of degradation impurities formed under the stress conditions employed were not discussed.…”

Section: Introductionmentioning

confidence: 99%

A novel validated UPLC method for quantitation of lopinavir and ritonavir in bulk drug and pharmaceutical formulation with its impurities

Killi

Maddinapudi²,

Dinakaran

et al. 2014

Braz. J. Pharm. Sci.

View full text Add to dashboard Cite

A simple gradient Ultra Performance liquid chromatographic method (UPLC) was developed for determination of lopinavir and ritonavir from its related impurities and assay for the first time. This method involves the use of a C18 (Acquity UPLC BEH C18, 50 × 2.1 mm, 1.7 µm) column thermostated at 30 o C using triethylamine (pH 2.2): 0.1% H 3 PO 4 in acetonitrile and methanol (85:15) as mobile phase in gradient elution mode. A Photo Diode Array (PDA) detector set at 215 nm was used for detection with flow rate 0.4 mL/min. This method was validated over the range of limit of quantitation (LOQ) to 50 to 150% of impurity specification limit and of working concentration for assay. The developed method was validated for linearity, range, precision, accuracy and specificity. This method was successfully applied for content determination of lopinavir and ritonavir in pharmaceutical formulations. This method can be conveniently used in quality control laboratory for routine analysis for assay and related substances as well as for evaluation of stability samples of bulk drugs and pharmaceutical formulations.Uniterms: Lopinavir/determination. Ritonavir/determination.Ultra Performance liquid chromatography/ qualitative analysis.Ultra Performance liquid chromatography/quantitative analysis. Bulk drugs/qualitative analysis. Pharmaceutical formulations/qualitative analysis. Pharmaceutical formulations/impurity profile. Bulk drugs/impurity profile.Desenvolveu-se, pela primeira vez, método de cromatografia líquida de ultra-eficiência (UPLC), com gradiente simples, para a determinação de lopinavir e ritonavir e suas impurezas relativas. Esse método envolve o uso de C18 (Acquity UPLC BEH C18, 50 × 2,1 mm, 1,7 µm), termostatizada a 30 o C, utilizandose trietilamina (pH 2,2) e fase móvel de H 3 PO 4 0,1% em acetonitrila e metanol (85:15), em eluição por gradiente. Detector de arranjo de fotodiiodo (PDA), fixado a 215 nm, foi utilizado para a detecção, com fluxo de 0,4 mL/min. Esse método foi validado em faixa de limite de quantificação (LOQ) de 50 a 150% de limite de impureza e da concentração de trabalho para o ensaio. O método desenvolvido foi validado quanto à linearidade, faixa, precisão, exatidão e especificidade. Esse método foi aplicado com sucesso para a determinação de lopinavir e de ritonavir em formulações farmacêuticas. Tal método pode ser convenientemente utilizado em laboratório de controle de qualidade, não só para análise de rotina e ensaio de substâncias relacionadas, como também para a avaliação da estabilidade de amostras a granel ou em formulações farmacêuticas.Unitermos: Lopinavir/determinação. Ritonavir/determinação. Cromatografia Líquida de Ultra Eficiência/ análise qualitativa.Cromatografia Líquida de Ultra Eficiência/análise quantitativa. Fármacos a granel/ análise qualitativa. Formulações farmacêuticas/análise qualitativa.Formulações farmacêuticas/perfil de impureza. Fármacos a granel/perfil de impureza. INTRODUCTIONLopinavir is an anti-Human immunodeficiency virus (HIV) drug which belongs to the class of drug...

show abstract

Section: Introductionmentioning

confidence: 99%

A novel validated UPLC method for quantitation of lopinavir and ritonavir in bulk drug and pharmaceutical formulation with its impurities

Killi

Maddinapudi²,

Dinakaran

et al. 2014

Braz. J. Pharm. Sci.

View full text Add to dashboard Cite

show abstract

“…On the contrary, reverse phase highperformance liquid chromatographic with ultraviolet detector (RP-HPLC-UV) method is feasible due to its easy accessibility and low cost. Also, many HPLC-UV methods for determination of plasma efavirenz (23,(26)(27)(28)(29)(30)(31) or simultaneous determination with other drugs such as anti-tuberculosis (anti-TB) agents or other antiretroviral agents (24,(32)(33)(34)(35)(36)(37)(38)(39)(40)(41)(42)(43)(44)(45)(46)(47)(48)(49)(50) have been reported. In most of these methods, the volumes of plasma used range from 200 to 900 μL (23,(26)(27)(28)33,34,(44)(45)(46), which were inapplicable for children due to the scarcity of sample.…”

Section: Introductionmentioning

confidence: 99%

A simple, rapid, economical, and practical method for the determination of efavirenz in plasma of Chinese AIDS patients by reverse phase high-performance liquid chromatography with ultraviolet detector

Yin

Meng

Dong

et al. 2014

BST

View full text Add to dashboard Cite

“…Lopinavir (the active ingredient) ( Figure 1A Literature survey revealed several analytical methods for the determination of ritoavir and lopinavir in tablets, capsules, and syrups which employ techniques such as high-performance liquid chromatography (HPLC) [2][3][4], Ultra performance liquid chromatography (UPLC) [5], and high performance thin layer chromatography (HPTLC) [6]. In biological fluids, the active principles as well as their metabolites have been quantitatively determined by HPLC with UV detection, LC/MS/MS [7,8], Spectroscopic method [9], Micellar electrokinetic chromatography method [10] and Tandem mass spectrometry [11].…”

Section: Introductionmentioning

confidence: 99%

Quantitative Estimation of Lopinavir and Ritonavir in Tablets by RP-HPLC Method

Jagadeeswaran¹,

Gopal²,

K³

et al. 2012

Pharm Anal Acta

View full text Add to dashboard Cite

A Simple HPLC Method for Simultaneous Determination of Lopinavir, Ritonavir and Efavirenz

Cited by 49 publications

References 6 publications

A novel validated UPLC method for quantitation of lopinavir and ritonavir in bulk drug and pharmaceutical formulation with its impurities

A novel validated UPLC method for quantitation of lopinavir and ritonavir in bulk drug and pharmaceutical formulation with its impurities

A simple, rapid, economical, and practical method for the determination of efavirenz in plasma of Chinese AIDS patients by reverse phase high-performance liquid chromatography with ultraviolet detector

Quantitative Estimation of Lopinavir and Ritonavir in Tablets by RP-HPLC Method

Contact Info

Product

Resources

About