A Profoundly Touchy Approved Spectrofluorimetric Approach for Assurance of Ixabepilone as Anticancer Drug by Utilizing Its Quenching Impact on Acetoxymercuric Fluorescein Reagent

A dependable, sensitive, basic and cheap spectrofluorimetric approach has been created for test of sulfur-containing drug; ixabepilone in bulk powder, vials and human plasma. The approach depends on the quenching effect of ixabepilone on the fluorescence intensity of acetoxymercuric fluorescene (AMF) reagent at λem of 530 nm and λex of 500 nm. Parameters which will control the reaction such as pH, AMF solution concentration, temperature, time and solvents were examined and optimized. According to the optimized conditions, the proposed approach was practiced over the concentration area of 20-100 ng mL-1 with adequate linearity (r = 0.9998). The developed approach was approved confirming to ICH rules in terms of accuracy, precision, linearity, LOD and LOQ. The proposed approach was practiced to analyze ixabepilone in Ixempra® vials with satisfactory recovery % of 99.89 and RSE% of 1.24. The results achieved were compared to those achieved by an already reported HPLC approach.

Optimizing Solvent Selection and Processing Conditions to Generate High Bulk-Density, Co-Precipitated Amorphous Dispersions of Posaconazole

Co-precipitation is an emerging method to generate amorphous solid dispersions (ASDs), notable for its ability to enable the production of ASDs containing pharmaceuticals with thermal instability and limited solubility. As is true for spray drying and other unit operations to generate amorphous materials, changes in processing conditions during co-precipitation, such as solvent selection, can have a significant impact on the molecular and bulk powder properties of co-precipitated amorphous dispersions (cPAD). Using posaconazole as a model API, this work investigates how solvent selection can be leveraged to mitigate crystallization and maximize bulk density for precipitated amorphous dispersions. A precipitation process is developed to generate high-bulk-density amorphous dispersions. Insights from this system provide a mechanistic rationale to control the solid-state and bulk powder properties of amorphous dispersions.

Stability of Extemporaneously Compounded Suspensions of Trimethoprim and Sulfamethoxazole in Amber Plastic Bottles and Amber Plastic Syringes

Background: Trimethoprim (TMP) and sulfamethoxazole (SMX) are widely used, in combination, to treat or prevent various infections. Unfortunately, no liquid oral formulation is currently available in Canada for patients who are unable to swallow tablets. Objective: To evaluate the stability of suspensions of TMP and SMX (8 and 40 mg/mL, respectively) prepared in Oral Mix or Oral Mix SF vehicle (Medisca Pharmaceutique Inc) and stored for up to 90 days in amber plastic bottles or amber plastic syringes at 5°C or 25°C. Methods: Suspensions were prepared from bulk powder and from tablets in Oral Mix and Oral Mix SF vehicles, then transferred to amber plastic (polyethylene terephthalate glycol) bottles and plastic oral syringes and stored at 5°C and 25°C. Samples were collected on predetermined study days (0, 7, 14, 23, 45, 60, 75, and 90 days) and analyzed using a validated high-performance liquid chromatography – ultraviolet detection method. A suspension was considered stable if it maintained at least 90% of its initial concentration with 95% confidence. Observations of organoleptic characteristics such as colour and odour, as well as pH, were used to assess physical stability. Results: Suspensions prepared from bulk powder maintained concentrations of TMP and SMX of at least 97% of the initial concentration over the 90-day study period. No obvious changes in colour, odour, or pH were observed. However, acceptable suspensions could not be prepared from the commercial tablets. A persistent foam that developed at the surface of all suspensions prepared from tablets could result in inconsistent dosing. Conclusions: Extemporaneously compounded oral suspensions of TMP and SMX (8 and 40 mg/mL, respectively) prepared from bulk powder in Oral Mix and Oral Mix SF vehicles and stored in amber plastic bottles or syringes at 5°C or 25°C remained stable for at least 90 days. Suspensions made from tablets produced unacceptable formulations. RÉSUMÉ Contexte : Le triméthoprime (TMP) et le sulfaméthoxazole (SMX) sont largement utilisés conjointement pour traiter ou prévenir diverses infections. Malheureusement, aucune formulation liquide orale n’est actuellement disponible au Canada pour les patients incapables d’avaler des comprimés. Objectif : Évaluer la stabilité des suspensions de TMP et de SMX (respectivement 8 et 40 mg/mL) préparées dans un véhicule Oral Mix ou Oral Mix SF (Medisca Pharmaceutique Inc.) et stockées pendant 90 jours dans des flacons ou des seringues en plastique ambré à 5 °C ou 25 °C. Méthodes : Les suspensions ont été préparées à partir de poudre en vrac et de comprimés dans les véhicules Oral Mix et Oral Mix SF, puis transférées dans des flacons en plastique ambré (polyéthylène téréphtalate glycol) et dans des seringues orales en plastique et stockées à 5 °C et 25 °C. Des échantillons ont été recueillis à des jours prédéterminés (0, 7, 14, 23, 45, 60, 75 et 90 jours) et analysés à l’aide d’une méthode de détection par ultraviolet validée de chromatographie en phase liquide à haute performance. La suspension était jugée stable si elle préservait au moins 90 % de sa concentration initiale avec un seuil de confiance de 95 %. Les observations des caractéristiques organoleptiques, comme la couleur et l’odeur, ainsi que le pH, ont été faites pour évaluer la stabilité physique. Résultats : Les suspensions préparées à partir de poudre en vrac préservaient au moins 97 % de la concentration initiale de TMP et de SMX pendant la période d’étude de 90 jours. Aucun changement manifeste de couleur, d’odeur ou de pH n’a été observé. Cependant, les suspensions acceptables n’ont pas pu être préparées à partir des comprimés commerciaux. Une mousse homogène se formait à la surface de ces suspensions, ce qui pourrait entraîner un dosage incohérent. Conclusions : Les suspensions orales composées extemporanées de TMP et SMX (respectivement 8 et 40 mg/mL) préparées à partir de poudre en vrac dans des véhicules Oral Mix et Oral Mix SF et stockées dans des flacons ou des seringues en plastique ambré à 5 °C ou 25°C sont restées stables pendant au moins 90 jours. Les suspensions préparées à partir de comprimés ont donné des formulations inacceptables.

Two Validated Chromatographic Methods for Determination of Ciprofloxacin HCl, One of its Specified Impurities and Fluocinolone Acetonide in Newly Approved Otic Solution

Two sensitive, selective and precise chromatographic methods have been established for concomitant quantification of ciprofloxacin HCl (CIP), fluocinolone acetonide (FLU) along with ciprofloxacin impurity A (CIP-imp A). The first method was thin-layer chromatography (TLC-densitometry) where separation was accomplished using TLC silica plates 60 G.F254 as a stationary phase and chloroform–methanol–33%ammonia (4.6:4.4:1, by volume) as a developing system. The obtained plates were scanned at 260 nm over concentration ranges of 1.0–40.0, 0.6–20.0 and 1.0–40.0 μg band−1 for CIP, FLU and CIP-imp A, respectively. The second method was based on high-performance liquid chromatography using a Zorbax ODS column (5 μm, 150 × 4.6 mm i.d.) where adequate separation was achieved through a mobile phase composed of phosphate buffer pH 3.6–acetonitrile (45:55, v/v) at flow rate 1.0 mL min−1 with ultraviolet detection at 254 nm. Linear regressions were obtained in the range of 1.0–40.0 μg mL−1 for CIP, 0.6–20.0 μg mL−1 for FLU and 1.0–40.0 μg mL−1 for CIP-imp A. The suggested methods were validated in compliance with the International Conference on Harmonization guidelines and were successfully applied for determination of CIP and FLU in bulk powder and newly marketed otic solution.

Analysis of heavy metal contents in some commercial turmeric samples available at Dhaka, Bangladesh

Nowadays, the use of spices and other herbs have extensively increased due to their medicinal values all over the world. However, the monitoring of heavy metal contamination in spices has also been increased in recent years. A study has been conducted to determine the concentration of eight heavy metals such as Lead (Pb), Cadmium (Cd), Chromium (Cr), Arsenic (As), Zinc (Zn), Iron (Fe), Copper (Cu) and Manganese (Mn) in mainly three different types of turmeric samples (Curcuma longa). The turmeric samples analyzed were (i) Unpacked bulk powder available at three different local markets in Dhaka (ii) Packed and marketed by three branded companies, and (iii) Raw turmeric directly collected from different local farmlands. The samples were analyzed using Atomic Absorption Spectroscopy (AAS). The concentration of most of the heavy metals were found within the limit recommended by WHO (6.0000 ppm) except lead (12.3469 ppm) in unpacked-3 bulk sample. This study also showed the concentration of heavy metals were present in a lower amount in packed power samples compared to unpacked bulk powder samples. The result of this analysis would be helpful for public awareness in consumption of different spices. The concerned authorities who are responsible for monitoring and regulating the food chain in the market in our country may also get a great message about heavy metal contamination of spices. Jahangirnagar University J. Biol. Sci. 9(1 & 2): 13-20, 2020 (June & December)