Development and Validation of a RP-HPLC Method for Simvastatin Capsules

Marques-Marinho, Flávia Dias; Freitas, Bruna Diniz; Zanon, José Carlos da Costa; Reis, Ilka Afonso; Lima, Angélica Alves; Vianna-Soares, Cristina Duarte

doi:10.2174/1573412911309010003

Cited by 2 publications

(2 citation statements)

References 36 publications

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“…SIM quantification was performed with the Agilent 1260 Infinity instrument (Santa Clara, CA, USA) using a mobile phase composed of methanol: 0.1% phosphoric acid solution (90:10 v / v ) and a C18 reversed-phase column of 25 cm × 4.6 mm with a particle size of 5 μm (LichroCar, Merck, Frankfurt, Germany). An injection volume of 10 μL, a flow rate of 1.0 mL/min, and detection with a Diode Array detector G4212B (Santa Clara, CA, USA) at a wavelength of 238 nm and room temperature were used [ 18 ].…”

Section: Methodsmentioning

confidence: 99%

Co-Encapsulation of Simvastatin and Doxorubicin into pH-Sensitive Liposomes Enhances Antitumoral Activity in Breast Cancer Cell Lines

et al. 2023

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Doxorubicin (DOX) is a potent chemotherapeutic drug used as the first line in breast cancer treatment; however, cardiotoxicity is the main drawback of the therapy. Preclinical studies evidenced that the association of simvastatin (SIM) with DOX leads to a better prognosis with reduced side effects and deaths. In this work, a novel pH-sensitive liposomal formulation capable of co-encapsulating DOX and SIM at different molar ratios was investigated for its potential in breast tumor treatment. Studies on physicochemical characterization of the liposomal formulations were carried out. The cytotoxic effects of DOX, SIM, and their combinations at different molar ratios (1:1; 1:2 and 2:1), free or co-encapsulated into pH-sensitive liposomes, were evaluated against three human breast cancer cell lines (MDA-MB-231, MCF-7, and SK-BR-3). Experimental protocols included cell viability, combination index, nuclear morphological changes, and migration capacity. The formulations showed a mean diameter of less than 200 nm, with a polydispersity index lower than 0.3. The encapsulation content was ~100% and ~70% for DOX and SIM, respectively. A more pronounced inhibitory effect on breast cancer cell lines was observed at a DOX:SIM molar ratio of 2:1 in both free and encapsulated drugs. Furthermore, the 2:1 ratio showed synergistic combination rates for all concentrations of cell inhibition analyzed (50, 75, and 90%). The results demonstrated the promising potential of the co-encapsulated liposome for breast tumor treatment.

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Section: Methodsmentioning

confidence: 99%

Co-Encapsulation of Simvastatin and Doxorubicin into pH-Sensitive Liposomes Enhances Antitumoral Activity in Breast Cancer Cell Lines

et al. 2023

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“…The USP describes HPLC method for the estimation of simvastatin [2]. Spectrophotometric, colorimetric, modified glassy carbon electrode, RP-HPLC methods and various voltammetric techniques are reported for determination of simvastatin in pharmaceutical products [3][4][5][6][7][8][9]. Simvastatin with other drugs are determined by HPTLC, HPLC with UV detection and spectrophotometry in combined dosage forms .…”

Section: Introductionmentioning

confidence: 99%

New Validated Analytical Method for Determination of Simvastatin in Tablet Formulations by RP–HPLC

Ashour¹,

Omar²

2020

DDA

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RP–HPLC method has been developed and validated for the determination of simvastatin (SVS) in pure form and in tablets. Fluvastatin sodium was used as internal standard. The determination was performed on Nucleodur column C8 (250×4.6 mm i.d., 5 µm particle size); the mobile phase consisted of a mixture of phosphate buffer solution (KH2PO4 0.05 M, pH 4.83) and methanol (20:80, v/v), pumped at a flow rate 1.0 mL min−1 . Analyte was monitored by UV detection at 230 nm. The mean retention times for fluvastatin and simvastatin were about 4.40 and 9.00 min, respectively. The method was proved linear in the range of 3.5– 550.0 µg mL-1 and exhibited good correlation coefficient (r>0.9998) and excellent mean recovery (100.71– 102.18%). Very good limit of detection of 0.63 µg mL-1 was found for SVS. The method was validated statistically and by recovery studies for linearity, precision, repeatability, and reproducibility. This method was successfully applied to the determination of simvastatin content in four marketed brands from Syria. A good agreement between this method with the pharmacopoeial method for the determination of simvastatin in some real samples demonstrates that the proposed method is suitable to quantify simvastatin in pharmaceutical formulations.

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Development and Validation of a RP-HPLC Method for Simvastatin Capsules

Cited by 2 publications

References 36 publications

Co-Encapsulation of Simvastatin and Doxorubicin into pH-Sensitive Liposomes Enhances Antitumoral Activity in Breast Cancer Cell Lines

Co-Encapsulation of Simvastatin and Doxorubicin into pH-Sensitive Liposomes Enhances Antitumoral Activity in Breast Cancer Cell Lines

New Validated Analytical Method for Determination of Simvastatin in Tablet Formulations by RP–HPLC

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