Compatibility of Tacrolimus Ointment with Corticosteroid Ointments of Varying Potencies

2009 ◽  
Vol 13 (3) ◽  
pp. 140-145 ◽  
Author(s):  
Lisa Pappas ◽  
Alex Kiss ◽  
Jacob Levitt

Background: Tacrolimus is often coadministered with various topical corticosteroids in the treatment of steroid-responsive dermatoses; however, the stability of these products in combination has not been examined extensively. Objective: To assess the in vitro compatibility of three tacrolimus-corticosteroid ointment combinations compared with unmixed controls. Methods: Tacrolimus-clobetasol propionate, tacrolimus-desoximetasone, and tacrolimus-hydrocortisone-17-valerate ointment combinations were prepared, stored with unmixed ointments at three temperature/humidity conditions, and evaluated for stability at days 0, 1, 2, 7, 14, and 28 via reverse-phase high-performance liquid chromatography. Results: There was no significant difference in the rate of drug degradation in mixed and unmixed ointments over time or across temperatures for tacrolimus (time p = .94; temperature p = .44), clobetasol (time p = .98, temperature p = .30), desoximetasone (time p = .98; temperature p = .94), or hydrocortisone-17-valerate (time p = .87, temperature p = .36). Limitations: This study did not examine the compatibility of tacrolimus with nonointment formulations. Conclusion: Tacrolimus-clobetasol propionate (superpotent), tacrolimus-desoximetasone (high potent), and tacrolimus-hydrocortisone-17-valerate (midpotent) ointment combinations are chemically compatible for at least 4 weeks.

2005 ◽  
Vol 187 (4) ◽  
pp. 1287-1292 ◽  
Author(s):  
Tatsuya Fukushima ◽  
Toshihiko Kitajima ◽  
Junichi Sekiguchi

ABSTRACT A polysaccharide deacetylase homologue, PdaA, was determined to act as an N-acetylmuramic acid deacetylase in vitro. Histidine-tagged truncated PdaA (with the putative signal sequence removed) was overexpressed in Escherichia coli cells and purified. Measurement of deacetylase activity showed that PdaA could deacetylate peptidoglycan treated with N-acetylmuramoyl-l-alanine amidase CwlH but could not deacetylate peptidoglycan treated with or without dl-endopeptidase LytF (CwlE). Reverse-phase high-performance liquid chromatography and mass spectrometry (MS) and MS-MS analyses indicated that PdaA could deacetylate the N-acetylmuramic acid residues of purified glycan strands derived from Bacillus subtilis peptidoglycan.


Author(s):  
Javed S Shaik ◽  
Nutan N Rao

Objective: The present study describes the stability indicating reverse-phase high-performance liquid chromatography (RP-HPLC) method for simultaneous estimation of amiloride hydrochloride and furosemide in pharmaceutical dosage forms.Methods: The proposed RP-HPLC method was developed using Shimadzu LC-2030 HPLC system equipped with UV detector, and chromatographic separation was carried on Shim-pack C18 (250 mm×4.6 mm, 5 μ) column at a flow rate of 1 ml/min and the runtime was 4min. The mobile phase consisted of water and acetonitrile in the ratio of 35:65, and elements were scanned using a UV detector at 281 nm.Results: The retention time of amiloride hydrochloride and furosemide was found to be 1.92 min and 3.14min, respectively. Linearity was found to be 12–28 ppm for amiloride hydrochloride and 96–224 ppm for furosemide, respectively. Limit of detection and limit of quantification for amiloride hydrochloride were 0.381 ppm and 1.156 ppm and for furosemide were 2.00 ppm and 6.068 ppm, respectively.Conclusion: The stability indicating method was developed by subjecting the drugs to stress conditions such as acid and base hydrolysis, oxidation, humidity, photolytic, and thermal degradation, and the degraded products formed were resolved successfully from the samples.


2020 ◽  
Vol 11 (02) ◽  
pp. 262-270
Author(s):  
Nathi Rathnakar ◽  
Dannana Gowri Shanker

The developed method was validated according to ICH guidelines with respect to specificity, linearity, limits of detection, quantification, accuracy, precision, and robustness. The stability-indicating reverse-phase high-performance liquid chromatography (RP-HPLC) method is precise; it has been developed for the simultaneous estimation of assay of guaifenesin (GN) and dextromethorphan hydrobromic (HBr) (DN) in drug substance and drug product. The chromatographic separation was done in an isocratic mode using the Syncronus C8 (250 × 4.6 mm, 5 μ particle size) column with mobile phase containing a 10 mM ammonium acetate in water (modulated pH 4.30 with orthophosphoric acid) and acetonitrile in the ratio of 60:40 (% v/v) used for efficient chromatographic separation. The flow rate of the mobile phase was 1 mL/min with ambient column temperature and detection of wavelength at 279 nm; injection volume 10 μL was fixed for achieving good elution of eluents. The retention time for GN was found to 3.46 minutes and DN was found to 7.58 minutes. GN and DN were linear in the concentration range from 357 to 1,428 and 19 to 75 μg/mL, respectively. Regression analysis showed that the r value (correlation coefficient) greater than 0.999 for GN r value was found to be 0.999, GN r value was found to be 0.999, DN r value was found to be 0.999. Limit of detection (LoD) and limit of quantification (LoQ) of GN was found to be 0.151 and 0.904 μg/mL, DN was found to be 0.241 and 0.726 μg/mL. The developed method was validated and found to be accurate, specific, and robust. Both the drugs were subjected to the stress conditions like acidic, basic, oxidative, photolytic, and thermal conditions. The degradation results were found to be satisfactory. In peroxide stress condition, GN was found stable over DN, and DN was found to degrade significantly. The degradation products were well resolved from GN, DN, and their impurities. The peak purity test results confirmed that the GN and DN peak were homogenous and pure in all stress conditions, thus, proving the stability-indicating nature of the method. This method could be applied for the simultaneous estimation of GN and DN in drug substance and drug product.


1986 ◽  
Vol 153 (2) ◽  
pp. 230-234 ◽  
Author(s):  
Koon-Sea Hui ◽  
Maria Hui ◽  
Fung-Chow Chiu ◽  
Miriam Banay-Schwartz ◽  
Teresita Deguzman ◽  
...  

Author(s):  
Mariola Dreger ◽  
Katarzyna Seidler-Łożykowska ◽  
Milena Szalata ◽  
Artur Adamczak ◽  
Karolina Wielgus

AbstractThe purpose of the study was to evaluate Chamerion angustifolium (L.) Holub genotypes for preliminary selection and further breeding programs aimed at obtaining a suitable industrial form for the pharmaceutical applications. Clonally propagated plants representing 10 genotypes of Ch. angustifolium were regenerated under in vitro conditions, hardened and planted in the field. Studies included an evaluation of shoot proliferation, phytochemical assessment of in vitro and ex vitro plants as well as investigations of intraspecies variability regarding four phenological stages: vegetative, beginning of blooming, full blooming, and green fruit phases. Quantitative and qualitative analyses of bioactive compounds were performed using high-performance liquid chromatography coupled with diode array detector and tandem mass spectrometer (HPLC–DAD–MS/MS) and high-performance liquid chromatography (HPLC) methods. The efficiency of shoot multiplication varied between genotypes from 8.12 to 21.48 shoots per explant. A high reproduction rate (> 20 shoots per explant) was recorded for four lines (PL_45, PL_44, PL_58, DE_2). Plants grown in vitro synthesized oenothein B (11.2–22.3 mg g−1 DW) and caffeic acid derivatives. Plants harvested from field contained the full spectrum of polyphenols characteristic for this species, and oenothein B and quercetin 3-O-glucuronide were the most abundant. The maximal content of oenothein B was determined in the vegetative phase of fireweed, while some flavonoids were found in the highest amount in full blooming phase. The results of analysis of variance indicated significant differences among genotypes in oenothein B, 3-O-caffeoylquinic acid and flavonoids accumulation in four phenological phases. PL_44 plants were characterized by high content of oenothein B and quercetin 3-O-glucuronide as well as a relatively high level of other flavonoids. Based on our phytochemical and micropropagation studies, PL_44 genotype was the best candidate for early selection and further breeding programs.


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