Development and validation of a HPLC‐PDA bioanalytical method for the simultaneous estimation of Aliskiren and Amlodipine in human plasma

Mannemala, Sai Sandeep; Nagarajan, Janaki Sankarachari Krishnan

doi:10.1002/bmc.3279

Cited by 21 publications

(9 citation statements)

References 21 publications

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“…Retention times of LND and IS were 4.5and 6.7 min respectively. The calibration curves were linear in the range of 0.5-30 µg/mL(r = 0.997) in NPs, and 20-600 ng/mL(r=0.998) in rat plasma, suggesting that the method was linear over the selected range (Mannemala, Nagarajan, 2015b). The intra and inter-day accuracy and precision were within CV%≤ 6%, indicating the method meets the acceptance criteria (FDA, 2001).…”

Section: Analytical Conditionsmentioning

confidence: 71%

Ameliorating the antitumor activity of lenalidomide using PLGA nanoparticles for the treatment of multiple myeloma

Karri

Dhandapani

Mannemala

et al. 2017

Braz. J. Pharm. Sci.

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Lenalidomide (LND) is an anti-cancer drug and an effective derivative of thalidomide used for multiple myeloma therapy. Because of its poor solubility in water, LND is known to cause low oral bioavailability (below 33%), and as a direct consequence of this, the dosing frequency is extended thus increasing risk of toxicity. To improve its bioavailability and sustained release, the present study aims to formulate polymeric nanoparticles (NPs) for LND using [Poly (lactic-co-glycolic acid)] (PLGA) as a polymer. The polymeric NPs were evaluated for particle size, SEM, XRD, drug content, entrapment efficiency (EE), in vitro release studies and in vivo bioavailability studies in rats. The formulated NPs possessed a size of 179±0.9 nm and a zeta potential of -24.4 ± 0.2 mV. The drug loading and EE of the optimized formulation was 32 ± 0.37 % and 78 ± 0.92% respectively. After oral administration of LND PLGA-NPs, the relative bioavailability was enhanced about 3.67-fold compared to LND. This study demonstrates the novel drug delivery for LND with PLGA-NPs as effective drug delivery system for sustained delivery of LND. Uniterms:Multiple myeloma/treatment. Lenalidomide/uses. PLGA/sustained release. Polymeric nanoparticles/development. Solubility.

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Section: Analytical Conditionsmentioning

confidence: 71%

Ameliorating the antitumor activity of lenalidomide using PLGA nanoparticles for the treatment of multiple myeloma

Karri

Dhandapani

Mannemala

et al. 2017

Braz. J. Pharm. Sci.

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“…The selectivity of the method for determination of antimalarials in human plasma was assessed by analyzing the presence of potential chromatographic interferences of plasma endogenous compounds at the retention times of PYT, SFD, MFL, ART, LFT, and IS. For this, the blank plasma samples obtained from six different subjects was processed and the chromatograms were compared with spiked plasma samples .…”

Section: Methodsmentioning

confidence: 99%

Development and validation of a generic liquid chromatographic method for the simultaneous determination of five commonly used antimalarial drugs: Application to pharmaceutical formulations and human plasma

Mannemala

Nagarajan

2015

J of Separation Science

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A simple, sensitive, and rapid liquid chromatographic method was developed and validated using diode array detection for the determination of five commonly used antimalarial drugs in pharmaceutical formulations and in human plasma. Chromatographic separation of antimalarial drugs and internal standard (ibuprofen) was achieved on a C18 column with a mobile phase composed of 10 mM dipotassium orthophosphate at pH 3.0, methanol, and acetonitrile in a ratio of 20:38:42 v/v, at a flow rate of 1 mL/min. The analytes were monitored at 220 nm and separated in ˂10 min. The method was validated for linearity, accuracy, precision, limit of quantification, and robustness. Both intra- and interday precisions (in terms of %RSD) were lower than 3% and accuracy ranged from 98.1 to 104.5%. Extraction recoveries were ≥96% in plasma. The limits of quantitation for artemether, lumefantrine, pyrimethamine, sulfadoxine, and mefloquine were 0.3, 0.03, 0.06, 0.15, and 0.15 μg/mL in human plasma. Stability under various conditions was also investigated. The method was successfully applied for quantification of antimalarial drugs in marketed formulations and in spiked human plasma. The method can be employed for routine QC purposes and in pharmacokinetic investigations.

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“…Recovery of the IS was also evaluated by calculating the peak area ratio of the IS from the spiked processed plasma samples and aqueous solutions at equivalent concentrations. 38…”

Section: 3 Plasma Recoverymentioning

confidence: 99%

Optimization and Validation of a Sensitive HPLC–PDA Method for Simultaneous Determination of Torasemide and Spironolactone in Human Plasma using Central Composite Design

Subramanian¹

2015

ACSi

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A sensitive, accurate, precise and rapid HPLC-PDA method was developed and validated for the simultaneous determination of torasemide and spironolactone in human plasma using Design of experiments. Central composite design was used to optimize the method using content of acetonitrile, concentration of buffer and pH of mobile phase as independent variables, while the retention factor of spironolactone, resolution between torasemide and phenobarbitone; and retention time of phenobarbitone were chosen as dependent variables. The chromatographic separation was achieved on Phenomenex C 18 column and the mobile phase comprising 20 mM potassium dihydrogen ortho phosphate buffer (pH-3.2) and acetonitrile in 82.5:17.5 v/v pumped at a flow rate of 1.0 mL min-1. The method was validated according to USFDA guidelines in terms of selectivity, linearity, accuracy, precision, recovery and stability. The limit of quantitation values were 80 and 50 ng mL-1 for torasemide and spironolactone respectively. Furthermore, the sensitivity and simplicity of the method suggests the validity of method for routine clinical studies.

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Development and validation of a HPLC‐PDA bioanalytical method for the simultaneous estimation of Aliskiren and Amlodipine in human plasma

Cited by 21 publications

References 21 publications

Ameliorating the antitumor activity of lenalidomide using PLGA nanoparticles for the treatment of multiple myeloma

Ameliorating the antitumor activity of lenalidomide using PLGA nanoparticles for the treatment of multiple myeloma

Development and validation of a generic liquid chromatographic method for the simultaneous determination of five commonly used antimalarial drugs: Application to pharmaceutical formulations and human plasma

Optimization and Validation of a Sensitive HPLC–PDA Method for Simultaneous Determination of Torasemide and Spironolactone in Human Plasma using Central Composite Design

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