Validation and Uncertainty Estimation of an Ecofriendly and Stability-Indicating HPLC Method for Determination of Diltiazem in Pharmaceutical Preparations

Sadeghi, Fahimeh; Navidpour, Latifeh; Bayat, Sima; Afshar, Minoo

doi:10.1155/2013/353814

Cited by 18 publications

(11 citation statements)

References 30 publications

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“…However, the peaks were tailed and the resolution between the analytes did not meet the USP requirement. In our previous experiment with diltiazem analysis, which is a tertiary amine, we realized that using ethanol as organic modifier in mobile phase provided sharper peaks and better resolution between diltiazem and its impurity [ 16 ]. Therefore, ethanol was used instead of methanol in the composition of the mobile phase, which led to sharper peaks compared to a mobile phase consisting of methanol but the analytes were not well resolved.…”

Section: Resultsmentioning

confidence: 99%

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Validation of a Stability-Indicating RP-HPLC Method for Determination of L-Carnitine in Tablets

Khoshkam

Afshar

2014

International Scholarly Research Notices

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A rapid and stability-indicating RP-HPLC method was developed for determination of l-carnitine in tablets. The separation was based on a C18 analytical column using a mobile phase which consisted of 0.05 M phosphate buffer (pH = 3): ethanol (99 : 1), including 0.56 mg/mL of sodium 1-heptanesulfonate. Column temperature was set at 50°C and quantitation was achieved by UV detection at 225 nm. In forced degradation studies, the drug was subjected to oxidation, hydrolysis, photolysis, and heat. Among the different stress conditions, the exposure to acidic and basic conditions was found to be an important adverse stability factor. The method was validated for specificity, selectivity, linearity, precision, accuracy, and robustness. The applied procedure was found to be linear in l-carnitine concentration range of 84.74–3389.50 µg/mL (r 2 = 0.9997). Precision was evaluated by replicate analysis in which relative standard deviation (RSD) values for areas were found below 2.0%. The recoveries obtained (100.83%–101.54%) ensured the accuracy of the developed method. The expanded uncertainty (3.14%) of the method was also estimated from method validation data. Accordingly, the proposed validated and rapid procedure was proved to be suitable for routine analyzing and stability studies of l-carnitine in tablets.

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Section: Resultsmentioning

confidence: 99%

“…An expanded uncertainty budget was constructed for l -carnitine in pharmaceutical preparations by the RP-HPLC-UV method according to previously reported procedures [ 16 ].…”

Section: Methodsmentioning

confidence: 99%

Validation of a Stability-Indicating RP-HPLC Method for Determination of L-Carnitine in Tablets

Khoshkam

Afshar

2014

International Scholarly Research Notices

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“…Green RP-HPLC methods using ethanol-based mobile phases have been widely reported for the analysis of drugs in pharmaceutical formulations [ 38 , 39 , 40 , 41 , 42 , 43 , 44 , 45 , 46 , 47 , 48 , 49 , 50 , 51 , 52 , 53 , 54 ], as well as in biological samples [ 55 , 56 ] ( Table 1 ). For example, a HPLC/diode-array detector (DAD) method using EtOH as the organic solvent in the mobile phase and an octadecyl-grafted silica column, was developed and validated by our team for the analysis of statins (i.e., pravastatin, fluvastatin, and atorvastatin in high concentrated EtOH/water solutions) [ 42 ].…”

Section: Alternative Organic Solvents In Rp-hplcmentioning

confidence: 99%

Greening Reversed-Phase Liquid Chromatography Methods Using Alternative Solvents for Pharmaceutical Analysis

et al. 2018

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The greening of analytical methods has gained increasing interest in the field of pharmaceutical analysis to reduce environmental impacts and improve the health safety of analysts. Reversed-phase high-performance liquid chromatography (RP-HPLC) is the most widely used analytical technique involved in pharmaceutical drug development and manufacturing, such as the quality control of bulk drugs and pharmaceutical formulations, as well as the analysis of drugs in biological samples. However, RP-HPLC methods commonly use large amounts of organic solvents and generate high quantities of waste to be disposed, leading to some issues in terms of ecological impact and operator safety. In this context, greening HPLC methods is becoming highly desirable. One strategy to reduce the impact of hazardous solvents is to replace classically used organic solvents (i.e., acetonitrile and methanol) with greener ones. So far, ethanol has been the most often used alternative organic solvent. Others strategies have followed, such as the use of totally aqueous mobile phases, micellar liquid chromatography, and ionic liquids. These approaches have been well developed, as they do not require equipment investments and are rather economical. This review describes and critically discusses the recent advances in greening RP-HPLC methods dedicated to pharmaceutical analysis based on the use of alternative solvents.

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“…The aim of this study was to establish an analytical method which is speci ic and selective for Nys analysis in a commercial ointment product. This method was duly validated according to ANVISA regulations (Khoshkam and Afshar, 2014;Annapurna et al, 2012;Sadeghi et al, 2013;Ghari et al, 2013).…”

Section: Introductionmentioning

confidence: 99%

Fasten, simple, and specific stability of the avant-garde RP-HPLC method for estimation and validation of nystatin in pharmaceutical formulations

Al-Bahadily¹,

Chaloob²,

Oudah³

et al. 2019

ijrps

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In this study, a simple and reliable stability-indicating RP-HPLC method was developed and validated for the analysis of Nystatin in the pharmaceuticals. The chromatographic separation was performed in the isocratic mode on an Ion Pac column; Arcus EP‑C18; 5μm, 4.6×250 mm, 30 °C) using a mobile phase consisting of ammonium acetate 0.05 M buffer/ Methanol mixture (30:70) and a flow-rate of 1.0 mL/min with UV detection at 305 nm. The flow rate was set at 1.0 mL/min. The HPLC analysis method was validated in terms of linearity, precision, accuracy, specificity, and sensitivity, according to International Conference on Harmonization (ICH) guidelines. The results indicated that the retention time was 8 min, and no interferences were observed from the formulation excipients and stress degradation products. The specificity, linearity, precision, accuracy, LOD, and LOQ of the method were validated. The method was linear over the range of 5–500 μg/mL with an acceptable correlation coefficient (R2 = 0.9996). The method’s limit of detection (LOD) and quantification (LOQ) were 0.01 and 0.025 μg/mL, respectively. The results indicate that this validated method can be used as an alternative method for the assay of nystatin. This validated HPLC method could be used for routine analysis, quality control, and the stability of analysis of Nystatin formulations.

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Validation and Uncertainty Estimation of an Ecofriendly and Stability-Indicating HPLC Method for Determination of Diltiazem in Pharmaceutical Preparations

Cited by 18 publications

References 30 publications

Validation of a Stability-Indicating RP-HPLC Method for Determination of L-Carnitine in Tablets

Validation of a Stability-Indicating RP-HPLC Method for Determination of L-Carnitine in Tablets

Greening Reversed-Phase Liquid Chromatography Methods Using Alternative Solvents for Pharmaceutical Analysis

Fasten, simple, and specific stability of the avant-garde RP-HPLC method for estimation and validation of nystatin in pharmaceutical formulations

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