Development and Validation of a Stability-Indicative Turbidimetric Assay to Determine the Potency of Doxycycline Hyclate in Tablets

Ac, Kogawa; LK, TOMITA; Hrn, Salgado

doi:10.9735/0975-5276.4.8.316-321

Cited by 16 publications

(2 citation statements)

References 10 publications

Supporting

Mentioning

Contrasting

Order By: Relevance

“…Care in working with these two types of techniques is fundamental to ensure quality medicines for the population. [51][52][53] Dissolution method for tablets is important for the verification of dissolution profile and pharmacotechnical formula, since an excellent medicine is not sufficient if it does not dissolve properly. Rifaximin presents a dissolution method with reading in spectrophotometer in the ultraviolet region.…”

Section: Methodsmentioning

confidence: 99%

Status of Rifaximin: A Review of Characteristics, Uses and Analytical Methods

Kogawa

Salgado

2018

Critical Reviews in Analytical Chemistry

View full text Add to dashboard Cite

Rifaximin, an oral antimicrobial, has many advantages because it is selective intestine, has minimal adverse effects and is used for the treatment of some diseases such as hepatic encephalopathy, irritable bowel syndrome, travelers' diarrhea, ulcerative colitis, Clostridium difficile and acute diarrhea. Rifaximin in the form of 200 mg tablets is commercially available. The crystalline α form is therapeutically safe and effective. In most of the official compendia, rifaximin has no monograph and in none of them is there a monograph for rifaximin tablets. The literature, however, contemplates this gap with varied methods. The literature presents some methods for evaluation of rifaximin in both biological fluid and pharmaceutical product. High performance liquid chromatography stands out for the evaluation of rifaximin. Most of the methods reported in the literature are for pharmaceuticals products. They use (1) toxic organic solvents, harmful to the operator and the environment, and/or (2) buffer solution, which has a shorter service life and requires time-consuming washes of the chromatographic system generating more waste. So, this work aims to discuss (i) properties; (ii) applications; (iii) polymorphism and (iv) analytical methods of rifaximin by the look of green chemistry. This review shows an extremely current topic of great importance to the chemical-pharmaceutical area and everything it involves, since the analytical process until the impact on the environment in which it is embedded.

show abstract

Section: Methodsmentioning

confidence: 99%

Status of Rifaximin: A Review of Characteristics, Uses and Analytical Methods

Kogawa

Salgado

2018

Critical Reviews in Analytical Chemistry

View full text Add to dashboard Cite

show abstract

“…Stress testing encompasses the influence of temperature, humidity, light, oxidizing agent as well as susceptibility over a wide range of pH values 3,4 . Generally, HPLC and turbidimetric methods are employed to monitor the changes in concentration on exposer of drug to different stressed conditions [5][6][7] . A UV spectroscopic SIAM may have advantages over chromatographic techniques in terms of simplicity, economic and time consumption.…”

Section: Introductionmentioning

confidence: 99%

Development and Validation of Stability Indicating Assay Method of Doxycycline Hyclate by using UV-Spectrophotometer

Sahoo¹,

Sahoo²,

Mohapatra³

et al. 2023

J. Drug Delivery Ther.

View full text Add to dashboard Cite

In the present study a simple, rapid, sensitive, and cost-effective stability indicating UV- spectrophotometric method was developed of doxycycline hyclate in bulk form and validated as per ICH guidelines. The stability-indicating study of doxycycline hyclate was based on the forced degradation reactions of the drug under different ICH-prescribed stress conditions like acid, alkali, neutral, oxidation, thermal, and photolysis. The absorption maximum of the drug was shown at 270nm and methanol was selected as solvent on the basis of the solubility of the drug. A linear relation with a regression coefficient value (R2) of 0.999 indicates that the method follows Beer’s- Lambert’s law within the concentrations range of 5 - 50µg/ml. The detection limit and quantitation limit were found to be 0.53 µg/ml and 1.55 µg/ml respectively. The % of recoveries was found to be within the range of 98.87 -99.88 with a low % of RSD indicating the accuracy of the method for estimation of the drug. Under stressed conditions, significant degradation was found in alkali, neutral and oxidation conditions and found to be sensitive under thermal and photolytic conditions but stable to acidic hydrolytic conditions. The developed method was validated according to ICH guidelines and found accurate, precise, and specific, suggesting that the developed stability-indicating spectroscopic method could be successfully adopted to estimate doxycycline hyclate. Keywords: Doxycycline Hyclate; Stability Indicating method; UV spectrophotometer; Validation; Stress degradation.

show abstract