Development and validation of a RP-HPLC method for assay of Atorvastatin and its application in dissolution studies on thermosensitive hydrogel-based nanocrystals

Kurakula, Mallesh; Sobahi, Tariq R.; El-Helw, AM; Abdelaal, Magdy Y.

doi:10.4314/tjpr.v13i10.16

Cited by 15 publications

(13 citation statements)

References 11 publications

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“…Samples were then filtered through a 0.45 μm syringe filter (Millipore ® ) immediately before dilution, or when necessary. Concentrations of ATR were determined using a validated high performance liquid chromatography (HPLC) method reported by Kurakula et al 27 The dissolution experiments were carried out in triplicate.…”

Section: Methodsmentioning

confidence: 99%

Custom fractional factorial designs to develop atorvastatin self-nanoemulsifying and nanosuspension delivery systems – enhancement of oral bioavailability

Hashem¹,

Al-Sawahli²,

Nasr³

et al. 2015

DDDT

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Poor water solubility of a drug is a major challenge in drug delivery research and a main cause for limited bioavailability and pharmacokinetic parameters. This work aims to utilize custom fractional factorial design to assess the development of self-nanoemulsifying drug delivery systems (SNEDDS) and solid nanosuspensions (NS) in order to enhance the oral delivery of atorvastatin (ATR). According to the design, 14 experimental runs of ATR SNEDDS were formulated utilizing the highly ATR solubilizing SNEDDS components: oleic acid, Tween 80, and propylene glycol. In addition, 12 runs of NS were formulated by the antisolvent precipitation–ultrasonication method. Optimized formulations of SNEDDS and solid NS, deduced from the design, were characterized. Optimized SNEDDS formula exhibited mean globule size of 73.5 nm, zeta potential magnitude of −24.1 mV, and 13.5 μs/cm of electrical conductivity. Optimized solid NS formula exhibited mean particle size of 260.3 nm, 7.4 mV of zeta potential, and 93.2% of yield percentage. Transmission electron microscopy showed SNEDDS droplets formula as discrete spheres. The solid NS morphology showed flaky nanoparticles with irregular shapes using scanning electron microscopy. The release behavior of the optimized SNEDDS formula showed 56.78% of cumulative ATR release after 10 minutes. Solid NS formula showed lower rate of release in the first 30 minutes. Bioavailability estimation in Wistar albino rats revealed an augmentation in ATR bioavailability, relative to ATR suspension and the commercial tablets, from optimized ATR SNEDDS and NS formulations by 193.81% and 155.31%, respectively. The findings of this work showed that the optimized nanocarriers enhance the oral delivery and pharmacokinetic profile of ATR.

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Section: Methodsmentioning

confidence: 99%

Custom fractional factorial designs to develop atorvastatin self-nanoemulsifying and nanosuspension delivery systems – enhancement of oral bioavailability

Hashem¹,

Al-Sawahli²,

Nasr³

et al. 2015

DDDT

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“…Nanocrystals are having the atoms size in the range of 10-400 nm, prepared from nanosuspension consisting of the following steps. i) preparation of nanosuspension, ii) wet milling, iii) high pressure homogenization iv) nanocrystallization and v) spray drying [24,25] . Mallesh Kurakula et al, have investigated the efficacy of nanocrystals in enhancing the solubility and dissolution rate of Atorvastatin [26] .…”

Section: Novel Technologies In Delivery Of Poorly Soluble Drugsmentioning

confidence: 99%

Novel Approaches to Enhance Oral Bioavailability of Poorly Soluble Drugs

Gowthami

Krishna²,

Rao

2020

Int. J. Res. Pharm. Sci & Tech.

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Oral administration is considered as major, convenient route among all other routes of delivery, owing to several benefits. But, the poor solubility or enzymatic/metabolic activity are the major concerns in developing a successful formulation. About 40% of approved drugs which are in the current market and 90% of new drug molecules in the developmental pipeline are hydrophobic in nature. The challenge to formulate insoluble drugs has met with various approaches to overcome the problems related to solubility, application of nanotechnology is one amongst them. The present review deals with various nanocarriers and technologies that are proven to be effective in enhancing the bioavilability of poorly soluble drugs.

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“…HMG‐CoA is converted to mevalonate, which is a rate‐limiting step in the formation of cholesterol in the liver, by HMG‐CoA reductase, leading to reduced production of low density lipoprotein (LDL) and very low density lipoprotein (VLDL) cholesterol, the precursor of LDL‐cholesterol . Many methods have been reported that could estimate atorvastatin calcium alone using HPLC, spectrofluorimetry [ , 23 ] spectrophotometry, HPTLC, and capillary electrophoresis …”

Section: Introductionmentioning

confidence: 99%

First‐derivative synchronous spectrofluorimetric method for estimation of losartan potassium and atorvastatin in their pure forms and in tablets

et al. 2020

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Losartan potassium (LOS) and atorvastatin (ATR) are used in combination for longterm treatment of stroke and for treatment of hypertension with high-level cholesterol. Both drugs were simultaneously determined and validated using a novel, easy, fast, and economical first-derivative synchronous fluorescence spectroscopic method. Methanol was used as the solvent for both drugs at a Δλ 80 nm and with a scanning rate of 600 nm/min. Peaks were determined as at 288.1 nm and 263.6 nm for LOS and ATR, respectively. The proposed method was validated according to International Conference on Harmonization guidelines and, subsequently, the developed method was applicable to the analysis of the two compounds in their different formulations without interference from each other. Amplitude-concentration plots were rectilinear over the concentration ranges 1.0-10.0 μg/ml and 0.5-5.0 μg/ml for LOS and ATR, respectively. Detection limits were found to be 0.096 μg/ml and 0.030 μg/ml and quantitation limits were 0.291 μg/ml and 0.093 μg/ml for LOS and ATR, respectively. The proposed method was successfully applied to the analysis of both compounds in synthetic mixtures and in laboratory-prepared tablets. These results were in accordance with the results acquired using the comparison method, high-performance liquid chromatography. K E Y W O R D Satorvastatin, losartan potassium, prepared tablets, synchronous fluorescence spectroscopy

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Development and validation of a RP-HPLC method for assay of Atorvastatin and its application in dissolution studies on thermosensitive hydrogel-based nanocrystals

Abstract: Purpose: To develop and validate a novel reverse phase high performance liquid chromatographic (RP-HPLC) method for the quantification of atorvastatin in thermosensitive hydrogel

Cited by 15 publications

References 11 publications

Custom fractional factorial designs to develop atorvastatin self-nanoemulsifying and nanosuspension delivery systems – enhancement of oral bioavailability

Custom fractional factorial designs to develop atorvastatin self-nanoemulsifying and nanosuspension delivery systems – enhancement of oral bioavailability

Novel Approaches to Enhance Oral Bioavailability of Poorly Soluble Drugs

First‐derivative synchronous spectrofluorimetric method for estimation of losartan potassium and atorvastatin in their pure forms and in tablets

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Development and validation of a RP-HPLC method for assay of Atorvastatin and its application in dissolution studies on thermosensitive hydrogel-based nanocrystals

Abstract: Purpose: To develop and validate a novel reverse phase high performance liquid chromatographic (RP-HPLC) method for the quantification of atorvastatin in thermosensitive hydrogel

Cited by 15 publications

References 11 publications

Custom fractional factorial designs to develop atorvastatin self-nanoemulsifying and nanosuspension delivery systems &ndash; enhancement of oral bioavailability

Custom fractional factorial designs to develop atorvastatin self-nanoemulsifying and nanosuspension delivery systems &ndash; enhancement of oral bioavailability

Novel Approaches to Enhance Oral Bioavailability of Poorly Soluble Drugs

First‐derivative synchronous spectrofluorimetric method for estimation of losartan potassium and atorvastatin in their pure forms and in tablets

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Product

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About

Custom fractional factorial designs to develop atorvastatin self-nanoemulsifying and nanosuspension delivery systems – enhancement of oral bioavailability

Custom fractional factorial designs to develop atorvastatin self-nanoemulsifying and nanosuspension delivery systems – enhancement of oral bioavailability