HPLC method development and validation for rapid estimation of Etodolac related impurity-H in pharmaceutical dosage form

Siddiraju, Sridhar; Boga, Venkatesh

doi:10.1016/j.phme.2013.12.002

Cited by 2 publications

(2 citation statements)

References 3 publications

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“…It was observed that a small change in the wavelength of detection and pH of mobile phase did not affect the ratio of area under the peak of the chromatogram of ESA and IS [9] (table 2).…”

Section: Robustnessmentioning

confidence: 99%

Development and Validation of a New Rp HPLC Analytical Method for the Determination of Etodolac Succinic Acid Co-Crystals in Spiked Rabbit Plasma

THOMAS

Varkey

2023

Int J Curr Pharm Sci

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Objective: The aim of the study was to develop and validate a novel and sensitive HPLC method for the determination of Etodolac content in Etodolac succinic acid co-crystals in spiked rabbit plasma. Methods: Chromatographic separation was achieved on an Eclipse C18 column (4.6 mm,100 mm, 3.5 μm spherical particles) using acetonitrile: methanol: acetic acid (100%) (50:49:1) as the mobile phase at a flow rate of 0.8 ml/min and monitored at 278 nm. Tinidazole was used as the internal standard. The run time was 6 min. The method was validated to fulfill International Conference on Harmonisation (ICH) guidelines, which included specificity, linearity, limit of detection (LOD), limit of quantification (LOQ), accuracy, precision and robustness. Results: The calibration curve was linear over the concentration range from 2.5 to 15 μg/ml, and the lower limit of detection was 0.3700 μg/ml. and lower limit of quantification was 1.121μg/ml for determination in spiked rabbit plasma. The accuracy and precision of the method were within the acceptable limit of±2% at the lower limit of quantification. Conclusion: A simple, sensitive, rapid and reproducible RP-HPLC method was developed with short runtime and less flow rate. Statistical analysis of the method proved that this method is suitable for the estimation of Etodolac in Co-crystalin plasma. Hence this method can be employed in the routine assay of the Etodolac Succinic acid co-crystals.

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“…It was observed that a small change in the wavelength of detection and pH of mobile phase did not affect the ratio of area under the peak of the chromatogram of ESA and IS [9] (table 2).…”

Section: Robustnessmentioning

confidence: 99%

Development and Validation of a New Rp HPLC Analytical Method for the Determination of Etodolac Succinic Acid Co-Crystals in Spiked Rabbit Plasma

THOMAS

Varkey

2023

Int J Curr Pharm Sci

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“…Further, various analytical reports have shown validated quantification methods for the determination of 5-FU alone in samples of biological matrices employing GC/MS [12], HPLC [13,14], hydrophilic interaction liquid chromatography-APCImass spectrometry [15], liquid chromatography tandem mass spectrometry (LC-MS/MS) [16][17][18] and in pharmaceutical dosage forms such as polymeric nanoparticles [19] or ETD alone [20][21]. Furthermore, Table 1 summarizes the comparative data of analytical methods/chromatographic studies in chronological order carried out in the last decade on individual analytes 5-FU or ETD or in combination with the agents of other therapeutic class /analytes from the literature [22][23][24][25][26][27][28][29][30][31][32][33][34][35][36][37][38].…”

Section: Introductionmentioning

confidence: 99%

Facile validated HPLC method using photodiode array detector for the combined analysis of etodolac and 5-FU in bulk and tablet dosage form

et al. 2020

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The aim of the investigation was to develop and validate a reversed-phase high pressure liquid chromatography (RP-HPLC) method for the simultaneous estimation of etodolac (ETD) and 5-FU in bulk and coated tablet dosage form. The method was validated in terms of linearity, precision, accuracy, and specificity, LOD, and LOQ according to ICH guidelines. The standard instrument parameters were optimized using C18 reverse phase Inertsil® ODS (250 × 4.6 mm, 5µ particle size) column with system equipped with photodiode array (PDA) detector. An optimized ratio of mobile phase in RP-HPLC under low pressure gradient mode comprising of 60:40 % v/v of acetonitrile and di-potassium hydrogen phosphate buffer (pH 6.4; 25 mM), provided sharp peaks (having adequate molar absorptivity at λmax of 280 nm) with short retention time of 4.3+/-0.2 and 11.5+/-0.3 min for 5-FU and etodolac, respectively. Results indicated the method was linear, precise, accurate, rugged and robust with RSD values <2%. The percentage recoveries of both the drugs were within the limits of 90-110% at various spiked concentrations. The proposed method was found to be highly effective and could be successfully employed for the quantification of 5-FU and ETD in bulk drug and tablet formulations for routine analysis.

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HPLC method development and validation for rapid estimation of Etodolac related impurity-H in pharmaceutical dosage form

Cited by 2 publications

References 3 publications

Development and Validation of a New Rp HPLC Analytical Method for the Determination of Etodolac Succinic Acid Co-Crystals in Spiked Rabbit Plasma

Development and Validation of a New Rp HPLC Analytical Method for the Determination of Etodolac Succinic Acid Co-Crystals in Spiked Rabbit Plasma

Facile validated HPLC method using photodiode array detector for the combined analysis of etodolac and 5-FU in bulk and tablet dosage form

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