Photochemical stability of warfarin potassium in powdered pharmaceutical tablets

2021 ◽  
Vol 32 (2) ◽  
pp. 115-129
Author(s):  
Emi Horiguchi-Babamoto ◽  
Makoto Otsuka

BACKGROUND: Warfarin potassium (Wf) commercial tablets originally formulated for adults are ground before administration to pediatric patients and elderly patients with dysphagia. OBJECTIVE: The present study investigated the effect of tablet grinding on the photostability of four types of commercial Wf tablets and predicted the photostability of the tablet powders by chemometric analysis. METHODS: The photodegradation of Wf content was evaluated by reversed-phase column high-performance liquid chromatography with ultraviolet (HPLC-UV). RESULTS: The bulk Wf powder was relatively photostable, whereas ground Wf tablets underwent substantial photodegradation. The photostability of the ground powders of a brand-name Wf commercial tablet and three generic Wf commercial tablets was quantitatively assessed and compared. In certain cases, the Wf in all the three ground generic tablets was less photostable than in the ground brand-name tablets. After 28 days of light irradiation, the Wf content decreased to 69.79% in the brand-name tablets, while it was 31.90% in some generic tablets. To clarify the factors influencing the relative photostability in various Wf formulations, we analyzed the intermolecular interactions between the active ingredient and the excipients by partial least-squares regression analysis based on photostability screening for each additive. CONCLUSION: The results suggested that the additives light anhydrous silicic acid and povidone adversely affect the stability of Wf tablets. In addition, the light stability of ground tablets was affected considerably by their formulation.

Author(s):  
Muhammad Akram ◽  
Jamil Anwar ◽  
Ammar Z. Alshemarya ◽  
Yi-Fan Goh ◽  
Ahmed Sher Awan ◽  
...  

A simple, rapid and sensitive Spectrophotometeric method for the determination of fluoroquinolones; ciprofloxacin and levofloxacin have been performed in pure form and pharmaceutical tablets. Both drugs gave reddish complexes when treated with iron (III) chloride at pH 4.0. The drugs showed maximum absorption at 530 and 545 nm. In both cases linear calibration was obtained up to 0.9 mg/10 mL of the drug. Effect of different parameters like pH, temperature and time was also studied on the stability of the complexes. The percentage recoveries found by described method was in the range of 98.2---100.01 %. Standards were prepared from the pure compounds obtained from sigma-Aldrich Pharm. The method was successfully employed for the Assay of drugs in commercial formulations. Finally determination of the drugs was carried out through HPLC method which showed that there is no appreciable difference between the results of both the methods. Results revealed that proposed method is practically suitable for routine applications in quality control laboratories for the analysis of fluoroquinolones drugs.________________________________________GRAPHICAL ABSTRACT


Molecules ◽  
2020 ◽  
Vol 25 (17) ◽  
pp. 3874
Author(s):  
Sharina Shamsudin ◽  
Jinap Selamat ◽  
Maimunah Sanny ◽  
Nuzul Noorahya Jambari ◽  
Rashidah Sukor ◽  
...  

Heterocyclic amines (HCAs) are carcinogenic food toxicants formed in cooked meats, which may increase the risk of cancer development in humans. Therefore, in this study, the effect of stingless bee honey from different botanical origins on the formation of HCAs in grilled beef satay was investigated. HCAs concentration in grilled beef satay was determined by using high performance liquid chromatography (HPLC). In total, six of the most toxigenic HCAs representing aminoimidazo-azaarenes (AIAs) (MeIQx, 4,8-DiMeIQx, and PhIP) and amino carbolines (norharman, harman, and AαC) groups were identified in all the beef samples investigated. A significant reduction in HCAs was observed in grilled beef marinated in honey as compared to beef samples marinated in table sugar (control), in which the reduction of 95.14%, 88.45%, 85.65%, and 57.22% was observed in gelam, starfruit, acacia, and Apis honey marinades, respectively. According to the partial least squares regression (PLS) model, the inhibition of HCAs in grilled beef was shown to be significantly correlated to the antioxidant activity (IC50) of the honey samples. Therefore, the results of this study revealed that the addition of stingless bee honey could play an important role in reducing HCAs in grilled beef.


Author(s):  
Vaishali Mistry ◽  
Akshay Yelwe ◽  
Amey Deshpande

Objective: The present study describes the stability indicating reversed-phase high-performance liquid chromatography (RP-HPLC) method for simultaneous estimation of 5-fluorouracil and tegafur in pharmaceutical dosage forms.Method: 5-fluorouracil and tegafur the propose RP-HPLC method were developed by using Shimadzu Prominence-i LC-2030 HPLC system equipped with UV detector and chromatographic separation was carried on shim-pack gist c18 (250 × 4.6 mm, 5 μ) column at a flow rate of 1 ml/min and the run time was 10 min. The mobile phase consisted of methanol and water in the ratio of 50:50% v/v and elements were scanned using a UV detector at 271 nm.Result: The retention time of 5-fluorouracil and tegafur was found to be 2.74 and 3.66 min, respectively. A linearity response was observed in the concentration range of 13.4 μg/ml–31.3 μg/ml for 5-fluorouracil and 6 μg/ml–14 μg/ml for tegafur, respectively. Limit of detection and limit of quantification of 5-fluorouracil were 10.97 μg/ml and 33.26 μg/ml and for tegafur are 4.89 μg/ml and 14.83 μg/ml, respectively.Conclusion: The stability indicating that the method was developed by subjecting drugs to stress conditions such as acid and base hydrolysis, oxidation, photo and thermal degradation, and degraded products formed were resolved successfully from samples.


2011 ◽  
Vol 3 (2) ◽  
pp. 383-391
Author(s):  
M. Z. Sultan ◽  
M. A. Mazid ◽  
M. A. Rashid

Cephradine, one of the commonly used and widely prescribed antibiotics in Bangladesh, is usually formulated in the dosage forms of capsule, dry suspension and IV injection. The dry-suspension is instructed to re-disperse in pre-boiled cooled water before use. A reversed phase high performance liquid chromatographic method (HPLC) has been developed for determination of cephradine in pharmaceutical preparation. To study the stability of cephradine suspension formulated by Bangladeshi manufacturers in aqueous medium and buffer of different pHs at room temperature, a simple and rapid chromatographic method was developed using acetonitrile and monobasic sodium phosphate buffer as mobile phase in the ratio of 15:85 (v/v) over C-8 bonded silica at ambient temperature using a flow rate of 1.0 mL/min.  The study revealed that the potency of cephradine suspension was almost stable at room temperature up to 13 days in aqueous medium at pH between 4 and 5.Keywords: Cephradine; Suspension; HPLC; Potency; pH.© 2011 JSR Publications. ISSN: 2070-0237 (Print); 2070-0245 (Online). All rights reserved.doi:10.3329/jsr.v3i2.7024                J. Sci. Res. 3 (2), 383-391 (2011)


2020 ◽  
Vol 8 (1) ◽  
pp. 15-20
Author(s):  
Yuni Retnaningtyas ◽  
Nia Kristiningrum ◽  
Hidayah Dwi Renggani ◽  
Indah Purnama Sary

The stability indication of Reversed Phase-High Performance Liquid Chromatography (RP-HPLC) method was validated for quantitative determination of mangiferin on three species mango leaves (Mangifera odorata Griff, Mangifera foetida Lour, and Mangifera indica L.). The samples were extracted by maseration method using methanol and concentrated using rotary evaporator. The method carried out on stationary phase a purospher RP-18 endcapped (25 cm × 4.6 mm i.d., 5 µm) column with a mobile phase consisting of methanol: phosphoric acid 0.1% (v/v) (31:69); flow rate:0.8 mL/min; solvent methanol, detection was carried out at 258 nm. The analytical  performace this measurement is good with the value of linearity (r2=0.998), precision (%RSD=0.649%), and accuration (10.67%). The forced degradation studies were carried out according to the International Conference on Harmonization (ICH) guidelines. The results indicating that the complete separation between degradation products and mangiferin peak occured. The degradation limit of mangiferin 5–20% (according to the guideline of ICH) except in basic condition (100%). The method was succesful applied to determine of the mangiferin in  pakel (Mangifera foetida), kweni (Mangifera indica) and kopyor (Mangifera odorata) extract. The mangiferin content was obtained are pakel (9.95%), kopyor (7.40%) and kweni (Mangifera odorata) (2.49%) respectively.


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