New concept for HPTLC peak purity assessment and identification of drugs in multi-component mixtures

Hewala, Ismail I.; Bedair, Mona M.; Shousha, Sherif

doi:10.1016/j.talanta.2011.11.048

Cited by 18 publications

(10 citation statements)

References 6 publications

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“…Peak purity was also assessed as being an essential requisite of any separation technique to avoid any contribution from any coeluting component and to ensure methods’ specificity. For HPTLC chromatograms, UV‐absorption spectra were recorded for the two drugs’ bands in their standard and sample solutions at three levels: band start slope (s), band maximum (m) and band end slope (e) [10]. Two correlation coefficients (r s,m and r m,e ) were then calculated by the aid of WinCATS ® spectral correlation tool and found to surpass the required limit (0.9990).…”

Section: Resultsmentioning

confidence: 99%

“…It allows simultaneous analysis of numerous samples per run without restricting to narrow pH ranges or consuming large volumes of solvents [7][8][9]. The resolved peaks can be scanned at different wavelengths with the assessment of their purity to exclude any co-eluding components [10]. On the other hand, HPLC is regarded as the best choice for developing a stability-indicating analysis in the realm of liquid chromatography [11].…”

Section: Introductionmentioning

confidence: 99%

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Stability assessment of tamsulosin and tadalafil co‐formulated in capsules by two validated chromatographic methods

Rezk

Abdel-Moety

Wadie

et al. 2020

J of Separation Science

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The advent of a new pharmaceutical formulation evokes the need for examining the chemical stability of their constituents and establishing proper stability‐indicating methods. Herein, the stability of the newly co‐formulated Tamsulosin and Tadalafil were examined under different stress conditions. The acidic degradation of Tamsulosin yielded its sulfonated derivative, while Tadalafil was susceptible to both acidic and basic degradation. Two stability‐indicating chromatographic methods, namely; high‐performance thin‐layer chromatography and high‐performance liquid chromatography, have been developed. Significant high‐performance thin‐layer chromatography‐fractionation could be achieved by utilizing a stationary phase of silica gel 60 F254 and a mobile phase composed of ethyl acetate/toluene/methanol/ammonia (4:2:4:0.6, by volumes) with densitometric recording at 280 nm over a concentration range of 0.5–25 μg/band for both drugs. The HPLC‐separation could be reached on XBridge® C18 column isocraticaly by using a mobile phase having acetonitrile/phosphate buffer, pH 6.0 (45:55, v/v) pumped at a flow rate of 1.7 mL/min and applying diode array ultraviolet‐detection at 210 nm over a linearity range of 3–70 μg/mL for each drug. Specificity of the two methods was additionally assured via peak purity assessment. Moreover, the methods were distinctly exploited for evaluating the drugs’ stability in accelerated stability‐studied samples of Tamplus® capsules.

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Section: Resultsmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

Stability assessment of tamsulosin and tadalafil co‐formulated in capsules by two validated chromatographic methods

Rezk

Abdel-Moety

Wadie

et al. 2020

J of Separation Science

View full text Add to dashboard Cite

show abstract

“…This was done by comparing the R f values of the drug peaks in samples to that of the standard. Also, upon comparing the recorded spectra at different points of the chromatographic peak, the calculated correlation was not less than 0.999 indicating the homogeneity of the peaks (33). Moreover, achieving a perfect overlap of the recorded spectra of each drug in standard and combined dosage form confirms the peak purity and identity (Figure 3).…”

Section: Selectivity and Specificitymentioning

confidence: 82%

Development and Validation of a High-Performance Thin-Layer Chromatographic Method for the Simultaneous Determination of Two Binary Mixtures Containing Ketorolac Tromethamine with Phenylephrine Hydrochloride and with Febuxostat

et al. 2016

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A validated and highly selective high-performance thin-layer chromatography (HPTLC) method was developed for the determination of ketorolac tromethamine (KTC) with phenylephrine hydrochloride (PHE) (Mixture 1) and with febuxostat (FBX) (Mixture 2) in bulk drug and in combined dosage forms. The proposed method was based on HPTLC separation of the drugs followed by densitometric measurements of their spots at 273 and 320 nm for Mixtures 1 and 2, respectively. The separation was carried out on Merck HPTLC aluminum sheets of silica gel 60 F254 using chloroform-methanol-ammonia (7:3:0.1, v/v) and (7.5:2.5:0.1, v/v) as mobile phase for KTC/PHE and KTC/FBX mixtures, respectively. Linear regression lines were obtained over the concentration ranges 0.20-0.60 and 0.60-1.95 µg band(-1)for KTC and PHE (Mixture 1), respectively, and 0.10-1.00 and 0.25-2.50 µg band(-1) for KTC and FBX (Mixture 2), respectively, with correlation coefficients higher than 0.999. The method was successfully applied to the analysis of the two drugs in their synthetic mixtures and in their dosage forms. The mean percentage recoveries were in the range of 98-102%, and the RSD did not exceed 2%. The method was validated according to ICH guidelines and showed good performances in terms of linearity, sensitivity, precision, accuracy and stability.

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“…At first, calculation of the correlation coefficient (r s,m ) between the spectra extracted at peak start and peak maximum and the correlation coefficient (r e,m ) between the spectra extracted at peak end and peak maximum is performed. Then, mathematical interpretation of the significance of the correlation values was carried out to check the purity of the specified peaks ( Hewala et al, 2012 ). Fig.…”

Section: Resultsmentioning

confidence: 99%

Eco-friendly stability-indicating HPTLC micro-determination of the first FDA approved SARS-CoV-2 antiviral prodrug Remdesivir: Study of degradation kinetics and structural elucidation of the degradants using HPTLC-MS

Abo-Gharam

El-Kafrawy²

2022

Sustainable Chemistry and Pharmacy

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New concept for HPTLC peak purity assessment and identification of drugs in multi-component mixtures

Cited by 18 publications

References 6 publications

Stability assessment of tamsulosin and tadalafil co‐formulated in capsules by two validated chromatographic methods

Stability assessment of tamsulosin and tadalafil co‐formulated in capsules by two validated chromatographic methods

Development and Validation of a High-Performance Thin-Layer Chromatographic Method for the Simultaneous Determination of Two Binary Mixtures Containing Ketorolac Tromethamine with Phenylephrine Hydrochloride and with Febuxostat

Eco-friendly stability-indicating HPTLC micro-determination of the first FDA approved SARS-CoV-2 antiviral prodrug Remdesivir: Study of degradation kinetics and structural elucidation of the degradants using HPTLC-MS

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