Development of a highly sensitive high‐performance thin‐layer chromatography method for the screening and simultaneous determination of sofosbuvir, daclatasvir, and ledipasvir in their pure forms and their different pharmaceutical formulations

Saraya, Roshdy E.; Elhenawee, Magda; Saleh, Hanaa

doi:10.1002/jssc.201800567

Cited by 27 publications

(10 citation statements)

References 19 publications

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“…Different chromatographic separation techniques including TLC‐densitometric and RP‐HPLC methods were commonly applied for separation and simultaneous determination of different drug mixtures [38–42]. TLC‐densitometric method requires minimal sample preparation, time‐saving, and cost‐effective, and RP‐HPLC method is characterized by high selectivity and sensitivity.…”

Section: Resultsmentioning

confidence: 99%

Different chromatographic methods for determination of alogliptin benzoate, metformin hydrochloride, and metformin impurity in bulk and pharmaceutical dosage form

Magdy

Ali

Taha

et al. 2021

J of Separation Science

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Two simple, sensitive, and reproducible methods were developed for the determination of alogliptin and metformin hydrochloride in presence of metformin impurity “melamin” in pure form and in pharmaceutical formulation. Method (A) was a thin layer chromatographic method in which separation was achieved using ethyl acetate–methanol–formic acid (6:3.8:0.2, by volume) as a developing system followed by densitometric scanning at 230 nm. Method (B) was a high‐performance liquid chromatography method; separation was achieved on C18 column, the mobile phase consisted of a mixture of sodium lauryl sulfate buffer 0.1% w/v, pH 3: methanol in the ratio 70:30, v/v and measurement was done at 220 nm. System suitability testing parameters were calculated to ascertain the quality performance of the developed chromatographic methods. The proposed methods have been validated regarding accuracy, precision, and selectivity, moreover they have been successfully applied to Westirizide tablets containing both alogliptin and metformin hydrochloride, results indicate that there was no interference from additives. No significance difference was found when these methods were compared to the reported one.

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Section: Resultsmentioning

confidence: 99%

Different chromatographic methods for determination of alogliptin benzoate, metformin hydrochloride, and metformin impurity in bulk and pharmaceutical dosage form

Magdy

Ali

Taha

et al. 2021

J of Separation Science

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“…The discovery of directly acting antiviral drugs (DAADs) in 2011 and the fast development of new molecules resulted in fast and progressive eradication of hepatitis‐C virus (HCV) which had infected more than 170 million people worldwide 1 . In Egypt alone, about 14.1% of the population (about 10 million patients) was infected with HCV 2 . HCV have seven genotypes with different sensitivities to antiviral drugs.…”

Section: Introductionmentioning

confidence: 99%

Chemometry‐assisted UV‐spectrophotmetric methods for the simultaneous determination of paritaprevir, ritonavir, and ombitasvir in their combined tablet dosage forms: A comparative study

Sayed

Ibrahim

Sharaf

2021

Journal of Chemometrics

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The ternary mixture under study is a recent hepatitis‐C antiviral medicine composed of three new directly acting antiviral drugs, namely, ombitasvir, paritaprevir, and ritonavir. They are co‐formulated as a single‐dose combined tablet dosage form. With more than 170 million infected patients worldwide, a large production scales of antivirals medicine is expected, and hence, new simple and fast methodologies are required to cover millions of analyses that are done routinely in the different pharmaceutical quality control and research laboratories. Ultraviolet spectrophotometry represents sensitive, fast, and cheap tool of analysis in all research and quality control laboratories that can cover the massive quality control of these regimens. However, the simultaneous determination of these three drugs using multivariate chemometric methods represents a high challenge as their spectra are strongly overlapping besides the large difference in their potency within the same tablet. In this research paper, four new different multivariate chemometric methods were developed for their simultaneous determination, namely, classical least square (CLS), principal component regression (PCR), partial least squares (PLS), and genetic algorithm‐partial least squares (GA‐PLS) techniques. The validated methods do not require extraction, separation, or derivatization steps. A comparative study was conducted among the four developed methods. All methods provided satisfactory results, whereas GA‐PLS showed better analytical performance as it had the lowest error with good higher correlation coefficient. The methods were applied in the simultaneous determination of the three drugs in pure form and in their combined tablet dosage form. The comparison confirmed agreement of the values obtained for all techniques.

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“…This combination showed activity against HCV genotype-4 with sustained virologic response of 100% [3]. HCV genotype-4 has been considered the most difficult-to-treat genotype which accounts for more than 90% of the HCV infections in Egypt alone (about 14.1% of Egyptian population) [4, 5].…”

Section: Introductionmentioning

confidence: 99%

Development and validation of eco-friendly micellar-HPLC and HPTLC-densitometry methods for the simultaneous determination of paritaprevir, ritonavir and ombitasvir in pharmaceutical dosage forms

Ibrahim

Saraya

Saleh

et al. 2019

Heliyon

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Ombitasvir, ritonavir and paritaprevir are three recently discovered directly acting antiviral drugs (DAADs) used in combined single dose tablet dosage form for treatment of hepatitis-C viral infections (HCV). The methods of analysis followed by quality control and research laboratories are required to be economic and fast; however, these methods can also produce huge amounts of chemical waste. In this study two fast, economic and green HPLC and HPTLC methods were validated for the simultaneous determination of the three drugs. For HPLC, isocratic elution used a mixture of micellar aqueous mobile phase consisting of (0.15 M sodium lauryl sulfate and 0.01 M sodium dihydrogen phosphate, pH 6.2) and ethanol (56:44). Elution was done on RP-C18 Kinetix® column (5 μm, 150 mm × 4.6 mm ID) at flow 1 mL min -1 and 254 nm UV-detector. HPTLC separations were performed on Merck® (20 cm × 10 cm) aluminum HPTLC plates coated with silica gel 60F254 using a mobile phase, Methylene chloride: methanol: ethyl acetate: ammonia (25%), (5:1:3:1, v/v/v/v) respectively. The calibration curves were linear across ranges of 3–100 μg mL -1 and 0.1–2 μg/spot for both HPLC and HPTLC methods, respectively. The two methods were applied successfully for the determination of the three drugs under study in their combined tablets dosage forms.

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Development of a highly sensitive high‐performance thin‐layer chromatography method for the screening and simultaneous determination of sofosbuvir, daclatasvir, and ledipasvir in their pure forms and their different pharmaceutical formulations

Cited by 27 publications

References 19 publications

Different chromatographic methods for determination of alogliptin benzoate, metformin hydrochloride, and metformin impurity in bulk and pharmaceutical dosage form

Different chromatographic methods for determination of alogliptin benzoate, metformin hydrochloride, and metformin impurity in bulk and pharmaceutical dosage form

Chemometry‐assisted UV‐spectrophotmetric methods for the simultaneous determination of paritaprevir, ritonavir, and ombitasvir in their combined tablet dosage forms: A comparative study

Development and validation of eco-friendly micellar-HPLC and HPTLC-densitometry methods for the simultaneous determination of paritaprevir, ritonavir and ombitasvir in pharmaceutical dosage forms

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