Development and validation of stability-indicating RP-UPLC method for simultaneous estimation of thiocolchicoside and aceclofenac in combined dosage form

Balan, P.; Kannappan, N.

doi:10.3329/icpj.v3i7.19078

Cited by 9 publications

(6 citation statements)

References 8 publications

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“…The minimum concentration levels at which ACF can be reliably detected (LOD) and quantified (LOQ) were found to be 0.0692 µg/mL and 0.2076 µg/mL respectively ( Fig. 4 and Table 3) which was more sensitive than some of the other published methods (Ravisankar et al 2013, Balan andKannappan 2014). Signal to noise (S/N) ratio for LOD and LOQ was shown in Table 3 which was also within acceptable limits.…”

Section: Resultsmentioning

confidence: 54%

Simple RP-HPLC method for Aceclofenac quantitative analysis in pharmaceutical tablets

Sharmin¹,

Sohrab²,

Moni³

et al. 2020

PHAR

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A reverse phase liquid chromatographic method for estimation of Aceclofenac in bulk drug and tablet dosage form was developed and validated. The chromatographic conditions to achieve the highest performance parameters using octylsilyl column with guard filter were optimized. The separation was carried out using a mobile phase containing 10 mM Phosphate Buffer, pH 2.1 and methanol (30:70% v/v) pumped at a flow rate of 1.0 mL/min with detection at 272 nm. The method was shown to be linear in 19.8–148.5 μg/mL concentration range (regression coefficient of 0.999). The limit of detection (LOD) and limit of quantification (LOQ) was found to be 0.0692 μg/mL and 0.2076 μg/mL, respectively. The accuracy of the method was assessed by adding fixed amount of pre-analyzed sample to different standard solutions (80%, 100%, and 120% of the tested concentration) in triplicate. The percentage mean recoveries were 97.91% to 100.39% with %RSD values of 0.64–0.79. The method was found to be precise with %RSD value of 1.13 and 1.60 for intraday and interday precision study, respectively. The method specificity and robustness were also established. New and sensitive HPLC method for estimation of Aceclofenac has been developed, in respect to the reviewed analytical methods.

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Section: Resultsmentioning

confidence: 54%

Simple RP-HPLC method for Aceclofenac quantitative analysis in pharmaceutical tablets

Sharmin¹,

Sohrab²,

Moni³

et al. 2020

PHAR

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“…All the products were selectively separated and fully characterized by various 2D NMR and mass spectroscopic methods experiments. The degradation products DP-2 and DP-3 were reported as the impurities of aceclofenac [9][10][11][12][13][14]. However, to the best of our knowledge, this is the first report on the structure characterization of degradation product (DP-2).…”

Section: Resultsmentioning

confidence: 99%

“…The study showed that the degradant formed is diclofenac by comparison of its standard chromatogram in both acidic and basic stress conditions [9]. Other reports [10][11][12][13][14][15] were found on simultaneous estimation of aceclofenac along with other NSAIDs by HPLC . All the above cited literature revealed that the drug is unstable under various stress conditions tested and few other degradants were formed.…”

Section: Isolation and Structural Characterization Of Degradation Promentioning

confidence: 99%

Isolation and Structural Characterization of Degradation Products of Aceclofenac by HPLC, HRMS and 2D NMR

et al. 2019

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The stability of aceclofenac under stress conditions was assessed to identify the degradation products. So, it was subjected to stress conditions like acid, base and oxidation, according to ICH guideline Q1A (R2). One degradation product formed when the drug was subjected to acid stress. Three degradation products were formed during the basic stress condition. The drug substance was found to be stable to oxidative stress. The degradants formed during the stress were separated on a C-18 column using gradient preparative HPLC elution. The only product (DP-2) formed during the acid stress and this one is same as of one of the three degradation products (DP-1, DP-2, DP-3) were formed during base stress. 1D and 2D NMR spectra and mass spectral analysis supported the proposed structures for the products. The products DP-2 and DP-3 have been reported earlier but this is the first report of product DP-1 as a degradation product of aceclofenac.

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“…The solution was filtered through a Whatman filter paper and from the filtrate, 10 mL was transferred in a 50 mL volumetric flask and the volume was made up with the mobile phase. This solution was filtered again through a 0.45 mm filter before use [5].…”

Section: Preparation Of Sample Solutionmentioning

confidence: 99%

Simultaneous Determination of Paracetamol, Aceclofenac and Chlorzoxazone in Pharmaceutical Dosage Form by UHPLC Method

Kb¹,

Murugan²,

Ezhilarasan³

et al. 2017

J Chromatogr Sep Tech

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Aim: UHPLC method was developed and validated for the determination of Paracetamol, Aceclofenac and Chlorzoxazone in pharmaceutical dosage form.Methods: Separation was performed in Agilent technologies 1220 infinity LC system equipped with open lab CDS Chemstation software using Eclipse plus C18 (50 × 4.6 mm id, 1.8 µm) column with mobile phase containing 0.05% orthophosphoric acid, adjusted to pH 6.0 with triethylamine and acetonitrile in the ratio of 70:30 v/v with a flow rate of 0.5 mL/min and detection wavelength 270 nm. Results:The method was found to be linear in the concentration range of 161.59-484.77 µg/mL for paracetamol, 49.69-149.09 µg/mL for aceclofenac and 124.81-374.43 µg/mL for chlorzoxazone with correlation coefficient of 0.999 for all the three drugs respectively. The %RSD of 0.57, 0.45 and 0.60 for intra-day and 0.96, 0.88 and 0.84 for inter-day precision, respectively for of Paracetamol, Aceclofenac and Chlorzoxazone suggest the precision of the method as all these values are less than 2%. The method has shown good, consistent recoveries for of Paracetamol (99.90-99.95%), Aceclofenac (99.83-99.92%) and Chlorzoxazone (99.39-99.59%) which are close to 100%. Conclusion:The method was found to be accurate, precise, specific, robust and linear for the determination of Paracetamol, Aceclofenac and Chlorzoxazone in pharmaceutical dosage form.

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Development and validation of stability-indicating RP-UPLC method for simultaneous estimation of thiocolchicoside and aceclofenac in combined dosage form

Cited by 9 publications

References 8 publications

Simple RP-HPLC method for Aceclofenac quantitative analysis in pharmaceutical tablets

Simple RP-HPLC method for Aceclofenac quantitative analysis in pharmaceutical tablets

Isolation and Structural Characterization of Degradation Products of Aceclofenac by HPLC, HRMS and 2D NMR

Simultaneous Determination of Paracetamol, Aceclofenac and Chlorzoxazone in Pharmaceutical Dosage Form by UHPLC Method

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