A Novel Validated RP-HPLC-DAD Method for the Simultaneous Estimation of Metformin Hydrochloride and Canagliflozin in Bulk and Pharmaceutical Tablet Dosage form with Forced Degradation Studies

Panigrahy, Uttam Prasad; Reddy, A. Sunil Kumar

doi:10.13005/ojc/310328

Cited by 38 publications

(18 citation statements)

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“…The accuracy was received (indicating good accuracy of the current method) if percentage of recoveries were in the range of 98.00-102.00 % [20][21]27 .…”

Section: Validation Tlc-densitometric Methodsmentioning

confidence: 99%

Quantitative Analysis of L-Dopa (L-3,4-Dihydroxyphenylalanine) Content in Extracts of Various Products from Velvet Bean (Mucuna pruriens (L.) DC.) Tempe Processing

Ariani¹,

Matsjeh²,

Mustofa³

et al. 2016

Orient. J. Chem

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The research was focused on quantitative analysis of L-Dopa content in extracts of various products from velvet bean tempe processing. The procedures of velvet bean tempe processing were dehulling, soaking, steaming, inoculating with Raprima tempe inoculum that contain Rhizopus oligosporus NRRL 2771, packaging and fermenting at room temperature for 24, 48, 72 and 96 h, respectively. The products of velvet bean tempe processing were extracted with ethyl acetate followed by ethanol. Quantitative analysis of L-Dopa content in the extracts was performed by validated TLCDensitometric method. Extracts of dehulled velvet bean, pre-fermented velvet bean, velvet bean fermented for 24, 48, 72 and 96 h contained L-Dopa as much as 26.24%, 40.20%, 0.47%, 2.67%, 3.27% and 3.55% (w/w), respectively. From this report, we had useful information to develope a new nutraceutical from the product of velvet bean tempe processing with expected health benefits.

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“…The accuracy was received (indicating good accuracy of the current method) if percentage of recoveries were in the range of 98.00-102.00 % [20][21]27 .…”

Section: Validation Tlc-densitometric Methodsmentioning

confidence: 99%

Quantitative Analysis of L-Dopa (L-3,4-Dihydroxyphenylalanine) Content in Extracts of Various Products from Velvet Bean (Mucuna pruriens (L.) DC.) Tempe Processing

Ariani¹,

Matsjeh²,

Mustofa³

et al. 2016

Orient. J. Chem

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“…Detailed literature survey reveals that the many methods by HPLC and UV technique are available for the determination of the drugs individually or in combination with other drugs [9][10][11][12][13][14][15][16][17] . However no method available for quantitative determination of genotoxic impurity in canagliflozin.…”

Section: Fig 1: Chemical Structure Of (A) Canagliflozin and (B) 5-ammentioning

confidence: 99%

Validated HPLC Method for Determinition of 5-Amino- 2-Methyl Benzoic Acid in Canagliflozin Drug Substances

Srivastavá¹

2017

WJPPS

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A sensitive, cost-effective, reproducible HPLC method was developed and validate for the quantitative determination of genotoxic impurity 5-amino-2-methyl benzoic acid present in canagliflozin drug substance by applying the concept of threshold of toxicological concern, a limit of 5.0µg/g was calculated based on the maximum daily dose of the drug substance. The impurity was separated on X-terra MS C18, 250 mm x 4.6mm, 5µm analytical column with a mobile phase consisting of the 0.1 % Orthophosphoric acid and methanol with the gradient program at a flow rate 1.0mL/min. The effluent was monitored by UV detection at 228 nm with column temperature maintained at 35 °C and the injection volume 30μL. Validation activity was planned and completed based on the ICH guideline. The LOD and LOQ value were found to be 0.52µg/g and 1.51 µg/g and accuracy results were well in the range 97.99 to 103.46 %. The linearity curve showed the correlation coefficient of 0.9996 and method very sensitive.

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“…Identification of DPs plays a vital role in establishing the safety and therapeutic benefit of a drug. 8,9 A comprehensive literature search reveals that a few analytical methods such as ultraviolet (UV), high-performance liquid chromatography (HPLC) and liquid chromatography/mass spectrometry (LC/MS) have been reported for CAN, which include a UV spectroscopic method for determination of CAN in bulk and pharmaceutical dosage form, 10 stability-indicating assay methods 11,12 and bioanalytical methods. [13][14][15] However, characterization of DPs and their toxicity has not been reported.…”

Section: Introductionmentioning

confidence: 99%

Characterization of forced degradation products of canagliflozine by liquid chromatography/quadrupole time‐of‐flight tandem mass spectrometry and in silico toxicity predictions

Baira

Kalariya

Nimbalkar

et al. 2018

Rapid Comm Mass Spectrometry

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A Novel Validated RP-HPLC-DAD Method for the Simultaneous Estimation of Metformin Hydrochloride and Canagliflozin in Bulk and Pharmaceutical Tablet Dosage form with Forced Degradation Studies

Cited by 38 publications

References 0 publications

Quantitative Analysis of L-Dopa (L-3,4-Dihydroxyphenylalanine) Content in Extracts of Various Products from Velvet Bean (Mucuna pruriens (L.) DC.) Tempe Processing

Quantitative Analysis of L-Dopa (L-3,4-Dihydroxyphenylalanine) Content in Extracts of Various Products from Velvet Bean (Mucuna pruriens (L.) DC.) Tempe Processing

Validated HPLC Method for Determinition of 5-Amino- 2-Methyl Benzoic Acid in Canagliflozin Drug Substances

Characterization of forced degradation products of canagliflozine by liquid chromatography/quadrupole time‐of‐flight tandem mass spectrometry and in silico toxicity predictions

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