Development and validation of the stability-indicating LC–UV method for the determination of Cefditoren pivoxil

Annapurna, Mukthinuthalapati Mathrusri; Goutam, Shubhra; Anusha, S; Srinivas, Leela

doi:10.1016/j.jpha.2012.06.003

Cited by 10 publications

(9 citation statements)

References 2 publications

(2 reference statements)

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“…Accuracy and precision data for intra- and inter-day assay are given in Table 2 . The assay values on both occasions (intra- and inter-day) were found to be within the acceptable limits [14] , [15] , [16] .…”

Section: Resultsmentioning

confidence: 99%

Assay method for quality control and stability studies of a new antimalarial agent (CDRI 99/411)

Khandelwal

Pachauri

Zaidi

et al. 2013

Journal of Pharmaceutical Analysis

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CDRI compound no. 99/411 is a potent 1,2,4-trioxane antimalarial candidate drug under development at our Institute. An HPLC method for determination of CDRI 99/411 with its starting material and intermediates has been developed and validated for in process quality control and stability studies. The analytical performance parameters such as linearity, precision, accuracy, specificity, limit of detection (LOD) and lower limit of quantification (LLOQ) were determined according to International Conference on Harmonization ICH Q2(R1) guidelines. HPLC separation was achieved on a RP-select B Lichrosphere® column (250 mm×4 mm, 5 μm, Merck) using water containing 0.1% glacial acetic acid and acetonitrile as the mobile phase in a gradient elution. The eluents were monitored by a photo diode array detector at 245 and 275 nm. Based on signal to noise ratio of 3 and 10 the LOD of CDRI 99/411 was 0.55 µg/mL, while the LLOQ was 1.05 µg/mL. The calibration curves were linear in the range of 1.05–68 µg/mL. Precision of the method was determined by inter- and intra-assay variations within the acceptable range.

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Section: Resultsmentioning

confidence: 99%

Assay method for quality control and stability studies of a new antimalarial agent (CDRI 99/411)

Khandelwal

Pachauri

Zaidi

et al. 2013

Journal of Pharmaceutical Analysis

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“…The accuracy of method was indicated by analysis of placebo-spiked CTP standard at three CTP concentration levels: 50, 100 and 150% where nine preparations had been injected on duplicate basis, the mean recovery for all concentration levels, in addition to the grand mean and standard deviation had been calculated and summarized in Table 5. The results of the proposed method were statistically compared to that of M. Mathrusri Annapurna et al stability indicating method [24] as reference method using Hypersil BDS® C18 (4.6 × 250 mm), 5 µm particle size column, water: Acetonitrile (50:50 v/v) as a mobile phase, flow rate of 1.2 mL min -1 and UV detection at 218 nm. The comparison indicated insignificant difference between both methods Table 6.…”

Section: Accuracymentioning

confidence: 99%

Quality by Design Approach for Establishment of Stability Indicating Method for Determination of Cefditoren Pivoxil

M¹,

He²,

Sm³

et al. 2018

J Pharm Anal Insights

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“…Since it is newly introduced as a drug, there are few determination methods for its assay in different samples: Ion selective electrode (Al-Tamimi et al, 2013), different kind of chromatography such as, planar chromatography (El-Bagary et al, 2013), gas chromatography (Telko and Hickey, 2007), inverse gas chromatography (Stapley et al, 2006), HPLC (Dhoka et al, 2011;Rieck and Platt, 2000;Srinivasa and Saraswathi, 2011;Dewani et al, 2010), LC (Annapurna et al, 2012), UPLC (Garg et al, 2011), spectrophotometric methods (Raju et al, 2009;Narala and Saraswathi, 2011) and stability indicating chromatographic method (Jayswal et al, 2011) have been devised for its determination.…”

Section: Introductionmentioning

confidence: 99%

Electrochemistry of cefditoren pivoxil and its voltammetric determination

Taşdemir

2016

Arabian Journal of Chemistry

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Electrochemical behavior of cefditoren pivoxil (CTP) was studied via experimental electrochemical methods and theoretical calculations performed at B3LYP/6-31+G(d)//AM1 level. Experimental studies were carried out based on an irreversible 4eÀ/4H+ reduction peak at ca. À0.8 V on hanging mercury drop electrode (HMDE) and irreversible 1eÀ/1H+ oxidation of CTP at ca. 0.8 V on glassy carbon electrode (GCE) versus Ag/AgCl, KCl (3.0 M) in Britton-Robinson buffer at pH 6.0 and 4.0, respectively. Tentative reduction and oxidation mechanisms were proposed based on computational and experimental results. Square-wave adsorptive stripping voltammetric methods have been developed and validated for quantification of CTP in different samples. Linear working range was established as 0.15-15.0 lM for HMDE and 1.0-50.0 lM for GCE. Limit of quantification (S/N = 10) was calculated to be (0.10 ± 0.02) lM and (0.80 ± 0.03) lM for HMDE and GCE, respectively. Methods were successfully applied to assay the drug in tablets and human serum with good recoveries between (99.2 ± 11.6) % and (102.5 ± 9.5) % having relative standard deviation less than 10%. ª 2014 Production and hosting by Elsevier B.V. on behalf of King Saud University. This is an open access article under the CC BY-NC-ND license (http://creativecommons.org/licenses/by-nc-nd/3.0/).

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Development and validation of the stability-indicating LC–UV method for the determination of Cefditoren pivoxil

Cited by 10 publications

References 2 publications

Assay method for quality control and stability studies of a new antimalarial agent (CDRI 99/411)

Assay method for quality control and stability studies of a new antimalarial agent (CDRI 99/411)

Quality by Design Approach for Establishment of Stability Indicating Method for Determination of Cefditoren Pivoxil

Electrochemistry of cefditoren pivoxil and its voltammetric determination

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