Development and Validation of HPTLC Method for Determination Apixaban in Bulk and Tablets

Jain, Hemant Kumar; Nikam, Vishal K.

doi:10.22159/ijap.2017v9i5.20028

Cited by 3 publications

(3 citation statements)

References 8 publications

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“…Pharmacovigilance studies and real studies on NOACs are revealing a high incidence of serious bleeding events that often require hospitalization and this demands regular plasma monitoring of NOACs [6]. Some high-performance thin-layer chromatography (HPTLC) methods are reported for the assay of NOACs and ROS either alone or in combination with other drugs in bulk & pharmaceutical formulations [, , , , , , , 7,8,9,10,11,12,13,14]. RIV is assayed using HPTLC in human plasma [15] and also HPTLC is used to quantify ROS in rabbit plasma [16].…”

Section: Introductionmentioning

confidence: 99%

ICH and US-FDA validated HPTLC methods with greenness assessments for the assay of mixtures prescribed in stroke prophylaxis: application to pharmaceutical preparations and human plasma

Hamdy

Korany

Ebied

et al. 2022

JPC-J Planar Chromat

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The importance of the binary mixtures of the novel oral anticoagulants (NOACs): apixaban (APX), edoxaban tosylate (EDX) and rivaroxaban (RIV) with the lipid-lowering statin, rosuvastatin calcium (ROS) is highly emerging to save lives of cardiovascular patients as these combinations are used in prophylaxis from stroke. A high-performance thin-layer chromatography (HPTLC) method was developed for the quantitative assay of these life-saving mixtures in tablets and human plasma. Two mobile phases were developed for the assay in bulk and tablets; the first one: toluene‒ethyl acetate‒methanol‒25% ammonia (3.5:4.5:2:0.2, V/V) (method I) used for the three mixtures, and the second one: methanol‒25% ammonia (9.95:0.05, V/V) (method II) used for EDX/ROS mixture only. For analysis in human plasma, APX was used as internal standard in RIV/ROS and EDX/ROS mixtures using methods I and II, respectively, while RIV was used as internal standard in APX/ROS mixture using method I; the methods were validated according to the Food and Drug Administration (FDA) regulation for analysis in biological fluids. The method selectivity was demonstrated by its ability to simultaneously analyze the drugs in the presence of dosage form excipients and in the presence of plasma interferences (analysis in biological fluid) at single wavelength (291 nm) by use of the internal standard.

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Section: Introductionmentioning

confidence: 99%

ICH and US-FDA validated HPTLC methods with greenness assessments for the assay of mixtures prescribed in stroke prophylaxis: application to pharmaceutical preparations and human plasma

Hamdy

Korany

Ebied

et al. 2022

JPC-J Planar Chromat

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“…Apixaban is not official in any of the Pharmacopoeia (USP, BP, EP-checked by online, IP-2014). According to literature survey,there are some HPLC, spectrofluorimetric and HPTLC methods reported for determination of apixaban [6][7][8][9] and hyphenated techniques such as LC-MS [10], UHPLC-MS/MS [11], either alone or ina combination tirofiban hydrochloride or with rivaroxaban.…”

Section: Introductionmentioning

confidence: 99%

Development and Validation of Stability Indicating HPTLC Method for Determination of Apixaban as Bulk Drug

Damle

Waghmare

Sinha

2019

Int J Pharm Pharm Sci

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Objective: To develop and validate simple, sensitive stability indicating HPTLC (High performance thin layer chromatography) method for apixaban. Methods: The chromatographic separation was performed on aluminium plates precoated with silica gel 60 F254 using toluene: ethyl acetate: methanol (3:6:1 v/v/v) as mobile phase followed by densitometric scanning at 279 nm. Results: The chromatographic condition shows sharp peak of apixaban at Rf value of 0.38±0.03. Stress testing was carried out according to international conference on harmonization (ICH)Q1A (R2) guidelines and the method was validated as per ICH Q2(R1) guidelines. The calibration curve was found to be linear in the concentration range of 100-500 ng/band for apixaban. The limit of detection and quantification was found to be 11.66ng/bandand35.33ng/band, respectively. Conclusion: A new simple, sensitive, stability indicating high performance thin layer chromatographic (HPTLC) method has been developed and validated for the determination of apixaban.

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“…Characterization of degradation products using multistage mass spectrometry was also reported 14 . Most of the reported methods are based on hyphenated techniques, and overall cost of the analysis using these techniques is more as compared to highperformance thin layer chromatography 15 . In this work, a simple, sensitive, accurate, precise and economic stability-indicating high-performance thin layer chromatographic procedure was developed.…”

mentioning

confidence: 99%

Untitled

2019

IJPSR

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A simple, accurate, precise, and rapid high-performance thin-layer chromatographic (HPTLC) method for determination of Apixaban (API) in bulk drug and the pharmaceutical formulation was developed and validated. The separation was performed on aluminum plates, pre-coated with silica gel 60F 254 as the stationary phase using toluene: methanol (7:3 v/v), as mobile phase. Densitometric measurement of the API was carried out at 290 nm. The retention factor (R f) was found to be 0.62 ± 0.04. The method was successfully validated as per International Conference on Harmonization (ICH) guidelines Q2 (R1). The calibration curve was linear in range 50-300 ng/band. The limits of detection and quantitation were 0.272 and 0.824 ng/band, respectively. Accuracy and precision of the proposed method were evaluated by recovery studies and intra-day and inter-day precision studies, respectively (standard deviation for precision studies was found to be less than 2). The developed method was used to analyze marketed formulation samples (tablet) of the API. The API was subjected to various stress conditions as per ICH Q1A (R2) guidelines. In stress studies, the drug showed significant degradation during acid, alkaline hydrolytic, and oxidative conditions. As the method could effectively separate the drug from their degradation products, it can be used as a stability indicating method.

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Development and Validation of HPTLC Method for Determination Apixaban in Bulk and Tablets

Cited by 3 publications

References 8 publications

ICH and US-FDA validated HPTLC methods with greenness assessments for the assay of mixtures prescribed in stroke prophylaxis: application to pharmaceutical preparations and human plasma

ICH and US-FDA validated HPTLC methods with greenness assessments for the assay of mixtures prescribed in stroke prophylaxis: application to pharmaceutical preparations and human plasma

Development and Validation of Stability Indicating HPTLC Method for Determination of Apixaban as Bulk Drug

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