Development and validation of a reversed-phase HPLC method for simultaneous analysis of butylhydroxyanisol, simvastatin and its impurities in tablet dosage forms

Karbane, Miloud El; Adnane, M.; AL-Kamarany, Mohammed Amood; Bouchafra, Houda; Cherrah, Yahia; Bouklouze, Abdelaziz

doi:10.1016/j.pharma.2014.03.002

Cited by 5 publications

(3 citation statements)

References 18 publications

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“…The degradation in simvastatin (SIM) was conducted in previous study with HPLC method [48][49][50][51], UPLC (52) and UV derivative spectrophotometry [53]. Samples were tested with neutral hydrolysis (water, 100 °C, 4 h), acid (1 N HCl, 100 °C, 4 h) and base (1 N NaOH, 100 °C, 4 h), oxidation (30 % H2O2…”

Section: Force Degradation Study Of Rosuvastatinmentioning

confidence: 99%

Forced Degradation Study of Statins: A Review

2018

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Forced degradation study is the degradation of new drug substances and drug products in more severe conditions than accelerated conditions. Forced degradation study were conducted to demonstrate the specificity of stability-indicating methods, providing insight into degradation pathways and drug degradation products, assisting in the elucidation of degradation product structures, identifying degradation products that could be spontaneously generated during storage and use of drugs and to facilitate improvement in manufacturing process and formulation corresponding with accelerated stability studies. Statins, a class of lipid-lowering medications, are the most widely prescribed drugs and an example of an unstable drug. Statins are susceptible to hydrolysis in the presence of high temperatures and humidity. Therefore, the review discusses various studies of forced degradation studies in six statins drug (atorvastatin, fluvastatin, pitavastatin, pravastatin, rosuvastatin, and simvastatin) to describe the drug's intrinsic stability thus it can assist the selection of formulations and packaging as well as proper storage conditions.

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Section: Force Degradation Study Of Rosuvastatinmentioning

confidence: 99%

Forced Degradation Study of Statins: A Review

2018

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“…In drug-drug interaction studies involving SV, several techniques have been developed for accurate determination of SV and SVA [36,37]. However, no technique has been developed for SV and SVA when SV is combined with silymarin.…”

Section: Introductionmentioning

confidence: 99%

Effects of Silymarin on the In Vivo Pharmacokinetics of Simvastatin and Its Active Metabolite in Rats

Liu¹,

Wu²,

Meng³

et al. 2019

Molecules

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Herein, the effect of silymarin pretreatment on the pharmacokinetics of simvastatin in rats was evaluated. To ensure the accuracy of the results, a rapid and sensitive UPLC–MS/MS method was established for simultaneous quantification of simvastatin (SV) and its active metabolite simvastatin acid (SVA). This method was applied for studying the pharmacokinetic interactions in rats after oral co-administration of silymarin (45 mg/kg) and different concentrations of SV. The major pharmacokinetic parameters, including Cmax, tmax, t1/2, mean residence time (MRT), elimination rate constant (λz) and area under the concentration-time curve (AUC0–12h), were calculated using the non-compartmental model. The results showed that the co-administration of silymarin and SV significantly increased the Cmax and AUC0–12h of SVA compared with SV alone, while there was no significant difference with regards to Tmax and t1/2. However, SV pharmacokinetic parameters were not significantly affected by silymarin pretreatment. Therefore, these changes indicated that drug-drug interactions may occur after co-administration of silymarin and SV.

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“…The analytical method followed for related substance test in SMV Tablets in both Pharmacopoeia is high performance liquid chromatography (HPLC) method of analysis [5][6][7] . The literature shows few methods for estimation of SMV along with its impurities are reported in the literature such as HPLC with Ultra-Violet detection [8][9][10][11][12] . The degradation behavior studies using ultra-high performance liquid chromatography (UHPLC)/Mass spectrometry (MS) is reported [1] .…”

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confidence: 99%

Quality-by-Design Based Development and Validation of Stability Indicating Method by UPLC Method for Impurities of Simvastatin from Drug and Pharmaceutical Dosage Form

Desai¹,

Nikalje²

2021

ijps

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Desai et al.: QbD based UPLC method development for Simvastatin impuritiesA rapid, robust and accurate ultra-high performance liquid chromatographic method was developed and validated for determination of impurities of simvastatin in drug and its pharmaceutical formulation. A systematic Quality-by-design approach was used for method development with the Fusion AETM software, to screen and optimize the column, mobile phase, column temperature, gradient time and other chromatographic conditions. The optimized method uses Waters Acquity Charged Surface Hybrid, Octadecylsilane C18 (1.7µm×2.1 mm×100 mm) column with gradient elution. Orthophosphoric acid pH was adjusted to 4.5 with triethylamine and acetonitrile with a ratio of (80:20) was used as mobile phase A, whereas methanol:acetonitrile (20:80) as mobile phase B, with a flow rate of 0.35 ml/min. Ultra Violet detector was programmed at 238 nm with a runtime of 13 min, wherein all the impurities were well resolved and were separated from main peak of simvastatin. The method was validated for accuracy, repeatability, reproducibility and robustness. All the validation parameters were in acceptable range. The linearity, limit of detection and limit of quantitation was established for all the impurities and for simvastatin. The method was also applied suitably for determining the degradation products of simvastatin using stress degradation studies

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Development and validation of a reversed-phase HPLC method for simultaneous analysis of butylhydroxyanisol, simvastatin and its impurities in tablet dosage forms

Cited by 5 publications

References 18 publications

Forced Degradation Study of Statins: A Review

Forced Degradation Study of Statins: A Review

Effects of Silymarin on the In Vivo Pharmacokinetics of Simvastatin and Its Active Metabolite in Rats

Quality-by-Design Based Development and Validation of Stability Indicating Method by UPLC Method for Impurities of Simvastatin from Drug and Pharmaceutical Dosage Form

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