Spectrophotometric determination of lesinurad and allopurinol in recently approved FDA pharmaceutical preparation

Mohamed, Ahmed A.; El‐Olemy, Ahmed; Ramzy, Sherif; Abdelazim, Ahmed H.; Omar, Mohamed K.M.; Shahin, Mohamed Y

doi:10.1016/j.saa.2020.119106

Cited by 21 publications

(8 citation statements)

References 2 publications

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“…The LOQ was 0.610 μ g mL –1 and 0.615 μ g mL –1 for ALLP by ratio difference and ratio derivative method and 2.736 μ g mL –1 for LSD. The repeatability and intermediate precision was evaluated through replicate analysis of ALLP at different concentration levels, and the % RSD was <2% (0.458–0.951%), indicating the high precision of the method [ 21 ].…”

Section: Methodsmentioning

confidence: 99%

A Brief Review of Analytical Methods for the Estimation of Allopurinol in Pharmaceutical Formulation and Biological Matrices

Sharma

Sapkota

Dangi

2021

International Journal of Analytical Chemistry

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This review article represents the collection and discussion of various analytical methods available in the literature for the determination of allopurinol (ALLP) in pharmaceutical and biological samples consisting of HPLC, UV-visible method, near-IR spectroscopy, spectrofluorometry, capillary electrophoresis, polarography, voltammetry, and hyphenated techniques such as LC-MS, LC-MS/MS, UPLC-MS/MS, and GC-MS. The anticipated review provides details about the comparative utilization of various analytical techniques for the determination of ALLP. The present review article can be effectively explored to conduct future analytical investigation for the estimation of ALLP.

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Section: Methodsmentioning

confidence: 99%

A Brief Review of Analytical Methods for the Estimation of Allopurinol in Pharmaceutical Formulation and Biological Matrices

Sharma

Sapkota

Dangi

2021

International Journal of Analytical Chemistry

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“…There have been numerous published analytical methods for the SME of LND and ALU in FDA-approved products. For the SME of LND and ALU in a standard drug and FDA-approved fixed-dose combination, conventional and greener spectrometry methods have been reported. For the SME of LND and ALU in an FDA-approved fixed-dose combination and human plasma, a spectrofluorimetry approach has also been reported .…”

Section: Introductionmentioning

confidence: 99%

Simultaneous Estimation of Lesinurad and Allopurinol in the New FDA-Approved Products Using a Greener Normal-Phase HPTLC Method: Greenness Assessment Using the NEMI, Analytical Eco-Score, ChlorTox, and AGREE Methods

Alam,

Shakeel,

Alshehri

et al. 2024

ACS Sustainable Chem. Eng.

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Recently, the U.S. Food and Drug Administration (FDA) approved combined dosage forms of lesinurad (LND) and allopurinol (ALU) in fixed-dose combinations to treat hyperuricemia associated with gout. For the simultaneous estimation (SME) of LND and ALU, neither conventional “high-performance thin-layer chromatography (HPTLC)” nor a greener HPTLC approach has been published to date. This study was carried out to design and validate a rapid, sensitive, and greener normal-phase HPTLC technique for the SME of LND and ALU in FDA-approved fixed-dose combination tablets. Ethyl acetate, ethanol, and water in a ternary ratio of 70:20:10 (v/v/v) were employed as a greener eluent system for the SME of LND and ALU. Normal-phase silica gel 60F254S plates were employed as the stationary phase. At a wavelength of 240 nm, LND and ALU were simultaneously estimated. The current method’s greenness was assessed using the National Environmental Method Index (NEMI), Analytical Eco-Scale (AES), ChlorTox, and Analytical GREENness (AGREE) methodologies. The current method was linear in the 30–1200 ng/band range for LND and ALU. The current approach was extensively validated and demonstrated to be accurate, precise, robust, sensitive, and greener for the SME of LND and ALU. The results of all greenness tools, including NEMI, AES (89), ChlorTox (0.96 g), and AGREE (0.81) showed that the current approach had an exceptional greener profile. Using the present methodology, the amounts of LND in FDA-approved fixed-dose combinations A and B were measured to be 98.73 and 99.17%, respectively. Using the present methodology, the amounts of ALU in FDA-approved fixed-dose combinations A and B were determined to be 99.27 and 100.58%, respectively. These data support the applicability of the current methodology for SME of LND and ALU in FDA-approved products. The findings of this study suggested that the current approach may be consistently applied to measure the LND and ALU in FDA-approved products.

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“…Meanwhile, spectrophotometric techniques are considered inexpensive and fast. This instrument is not only can be purchased and easily found in most labs but also can be operated by anyone who is not an expert in The spectrophotometers offer substitute resolutions for complex mixtures of analytes with the requirement of prior separation or extraction [15][16][17].…”

Section: Introductionmentioning

confidence: 99%

A Modest Uv Spectrophotometric Assisted by Chemometric Approach for Verification of Acetaminophen Level in Various Manufactured Tablets and Syrups in Indonesian Pharmacies

Munir¹,

Inayatullah

Salmani

et al. 2023

Int J App Pharm

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Objective: This study aimed to verify the paracetamol level in some fabricated tablets and syrups in Indonesian pharmacies. Methods: The fabricated tablets and syrups were analyzed using a spectrophotometer UV that was assisted by the chemometric approach. Partial least squares (PLS) and principal component regression (PCR) were the chemometric methods employed to verify the paracetamol level in pharmaceutical products. There were 25 different samples (tablets and syrups) applied in this study. The validation study was employed in this study to verify the approach according to the ICH guidelines. The double-distilled water was applied as a solvent before the samples were analyzed using a spectrophotometer. Results: This technique was efficient and require double-distilled water only as a solvent. The results of this study reveal that there was a deviation in absorbance of the samples with RSD ranging from (0.15-0.45). The technique was linear, ranging from 1.0–6.0 µg·ml-1, with an R2 (0.9991) obtained at 242 nm. The percentage recovery was applied to study the accuracy of the technique and was acquired at 99.18%. The results have shown that the approach was the potential to be applied in estimating the level of paracetamol in tablets and syrups. Conclusion: The detection of paracetamol levels in tablets and syrups using UV spectrophotometric showed satisfactory outcomes. The application of the chemometric approach by using PLC and PCR as the statistical assessment indicated that there was no significant distinction among the validated methods. Furthermore, the method can be used by industries particularly small industries to secure medicines that comply with Indonesian rules.

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Spectrophotometric determination of lesinurad and allopurinol in recently approved FDA pharmaceutical preparation

Cited by 21 publications

References 2 publications

A Brief Review of Analytical Methods for the Estimation of Allopurinol in Pharmaceutical Formulation and Biological Matrices

A Brief Review of Analytical Methods for the Estimation of Allopurinol in Pharmaceutical Formulation and Biological Matrices

Simultaneous Estimation of Lesinurad and Allopurinol in the New FDA-Approved Products Using a Greener Normal-Phase HPTLC Method: Greenness Assessment Using the NEMI, Analytical Eco-Score, ChlorTox, and AGREE Methods

A Modest Uv Spectrophotometric Assisted by Chemometric Approach for Verification of Acetaminophen Level in Various Manufactured Tablets and Syrups in Indonesian Pharmacies

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