HPLC determination of chloramphenicol degradation in eye drops

Boer, Ynto S. de; Pijnenburg, A.M.C.M.

doi:10.1007/bf01960984

Cited by 16 publications

(10 citation statements)

References 7 publications

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“…In both instances, the formulations were also protected from light. A study performed by Boer and Pijnenburg with CAM solutions (pH 7.2) under similar condition in the dark (4 °C and 21 °C) (Boer and Pijnenburg, 1983), showed the same kind of temperaturedependent difference in degradation of CAM as observed for our samples. The stability limitations of CAM is well-known, and is explained by CAM hydrolysis into a glycol-derivative and CHCl 2COOH in the presence of water (and light) (Lv et al, 2005).…”

Section: Storage Stabilitysupporting

confidence: 86%

Development and optimization of a new processing approach for manufacturing topical liposomes-in-hydrogel drug formulations by dual asymmetric centrifugation

Ingebrigtsen

Škalko‐Basnet

Holsæter

2016

Drug Development and Industrial Pharmacy

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Objectives: The objective of the present study was to utilize dual asymmetric centrifugation (DAC) as a novel processing approach for the production of liposomes-in-hydrogel formulations. Materials and Methods:Lipid films of phosphatidylcholine, with and without chloramphenicol (CAM), were hydrated and homogenized by DAC to produce liposomes in the form of vesicular phospholipid gels with a diameter in the size range of 200-300 nm suitable for drug delivery to the skin. Different homogenization processing parameters were investigated along with the effect of adding propylene glycol (PG) to the formulations prior to homogenization. The produced liposomes were incorporated into a hydrogel made of 2.5 % (v/v) soluble β-1,3/1,6-glucan (SBG) and mixed by DAC to achieve a homogenous liposomes-inhydrogel-formulation suitable for topical application.Results and Discussion: CAM-containing liposomes with a vesicle diameter of 282 ± 30 nm and polydispersity index (PI) of 0.13 ± 0.02 were successfully produced by DAC after 50 minutes centrifugation at 3500 rpm, and homogenously (< 4 % content variation) incorporated into the SBG hydrogel. Addition of PG decreased the necessary centrifugation time to 2 minutes and 55 seconds, producing liposomes of 230 ± 51 nm and PI of 0.25 ± 0.04. All formulations had an entrapment efficiency of approximately 50%. Conclusions:We managed to develop a relatively fast and reproducible new method for the production of liposomes-in-hydrogel formulation by DAC.

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Section: Storage Stabilitysupporting

confidence: 86%

Development and optimization of a new processing approach for manufacturing topical liposomes-in-hydrogel drug formulations by dual asymmetric centrifugation

Ingebrigtsen

Škalko‐Basnet

Holsæter

2016

Drug Development and Industrial Pharmacy

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“…Boer and Pijnenburg have developed an HPLC method for the simultaneous determination of chloramphenicol and its most important degradation products. C18-reversed phase column has been employed with a mobile phase consisting of boric acid solution and acetonitrile (60 : 40, v/v) adjusted to pH of 3.0 [4]. Seth and Bannerjee has also determined chloramphenicol in the presence of its degradation products in drug formulations by using polarographic method [5].…”

Section: Introductionmentioning

confidence: 99%

Analysis of Chloramphenicol and Its Related Compound 2-Amino-1-(4-nitrophenyl)propane-1,3-diol by Reversed-Phase High-Performance Liquid Chromatography with UV Detection

Al‐Rimawi

Kharoaf²

2011

Chromatography Research International

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A simple and stability-indicating liquid chromatographic method is developed for the analysis of chloramphenicol and its related compound 2-amino-1-(4-nitrophenyl)propane-1,3-diol in two pharmaceutical forms. Liquid chromatography with a UV detector at a wavelength of 278 nm using a reversed phase C18 stationary phase has been employed in this study. Isocratic elution is employed using a mixture of sodium pentanesulfonate solution (0.012 M), acetonitrile, and glacial acetic acid (85 : 15 : 1, v/v). This new method is validated in accordance with USP requirements for new methods for assay determination, which include accuracy, precision, specificity, linearity and range. This method shows enough selectivity, sensitivity, accuracy, precision, and linearity range to satisfy Federal Drug Administration/International Conference on Harmonization regulatory requirements. The current method demonstrates good linearity over the range of 0.04-0.16 mg/mL of chloramphenicol. The accuracy of the method is 100.0% with a relative standard deviation of 0.1%. The precision of this method reflected by relative standard deviation of replicates is 0.1%. The method is sensitive with a detection limit of 0.005% for chloramphenicol. The related substance of chloramphenicol (2-amino-1-(4-nitrophenyl)propane-1,3-diol) can be selectively determined with a good resolution in two pharmaceutical forms: eye ointment and eye drops.

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“…By comparing the HPLC chromatograms, UV and MS spectra with those of reference compounds, peak 1 was assigned to 2-amino-l-(4-nitrophenyl)-l,3-propanediol, a hydrolysis product of the amide group of chloramphenicol (a typical reaction in the photochemical degradation of CAP [9,10]). Peaks 4 and 6 were assigned to 4-nitrobenzoic acid and 4-nitrobenzaldehyde, respectively.…”

Section: Identification Of Degradation Products and Degradation Pathwaymentioning

confidence: 99%

Identification and evaluation of radiolysis products of irradiated chloramphenicol by HPLC-MS and HPLC-DAD

et al. 2002

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SummaryThe radiolysis products of chloramphenicol under y-radiation sterilization were investigated systematically. Eight main radiolysis products were identified and quantified by HPLC-MS and HPLC-DAD, including I',,vo compounds never before reported. The minor radiolysis products were quantified, which shows that they are at concentration levels < threshold for identification. Carbon-carbon rupture reaction and oxidation reaction are proposed as the main radiolysis reactions of chloramphenicol powder. The applicability of y-sterilization for chloramphenicol products was evaluated quantitativelywith qualitative and quantitative data that were compared to the threshold requirements of international regulations for identification. It was concluded that toxicities of the radiolysis products of chloramphenicol produced by y-radiation sterilization can be neglected, the radiolysis products are safe for human health from the chemical view.

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HPLC determination of chloramphenicol degradation in eye drops

Cited by 16 publications

References 7 publications

Development and optimization of a new processing approach for manufacturing topical liposomes-in-hydrogel drug formulations by dual asymmetric centrifugation

Development and optimization of a new processing approach for manufacturing topical liposomes-in-hydrogel drug formulations by dual asymmetric centrifugation

Analysis of Chloramphenicol and Its Related Compound 2-Amino-1-(4-nitrophenyl)propane-1,3-diol by Reversed-Phase High-Performance Liquid Chromatography with UV Detection

Identification and evaluation of radiolysis products of irradiated chloramphenicol by HPLC-MS and HPLC-DAD

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