An Exploratory Study of a New Vancomycin Eye Drops Formulation for Extemporaneous Compounding

2020 ◽  
pp. 001857872097388
Author(s):  
Pang Chen ◽  
Zin Mar ◽  
Anthony Giannetti ◽  
Susan Hughes ◽  
Justine Gilbert ◽  
...  
Keyword(s):  
High Performance ◽  
Antimicrobial Prophylaxis ◽  
Hplc Method ◽  
Stability Study ◽  
Initial Time ◽  
Eye Drops ◽  
Sterility Testing ◽  
Vancomycin Hydrochloride ◽  
Drug Concentrations ◽  
New Formulation

Purpose: Compounded eye drop solutions of vancomycin hydrochloride have important clinical applications, such as postoperative antimicrobial prophylaxis and bacterial keratitis. There exists a plethora of data to support the use of various liquid vehicles to compound vancomycin hydrochloride eye drops. However, there are a number of limitations for implementation, especially the frequent shortage or discontinuation of the vehicle products. This study was designed to investigate the use of an OTC eye wash product as the evergreen vehicle and to evaluate the physical and chemical stability of the new formulation. Methods: The Advance Eye Relief® eye wash and vancomycin hydrochloride for injection vials were used to prepare 10 and 50 mg/mL vancomycin eye drop solutions. The solutions were packaged in Steri-Droppers® bottles and stored in a freezer for 14 days followed by 28 days in refrigeration. The 14-day period of freezing was included to allow time for sterility testing. At pre-determined stability time points, samples were taken for visual inspection, pH and osmolality measurement, and analysis by a stability-indicating high performance liquid chromatography (HPLC) method. Results: Freshly prepared vancomycin eye drops were clear, colorless, and free of particulates. The pH readings were 7.03 and 6.28 for the 10 and 50 mg/mL solutions, respectively. The osmolality of both solutions were within the range of 300-330 mOsmol/kg and considered isotonic. Initial drug concentrations of all samples were confirmed by HPLC to be within 100%-103% of the label claims. Throughout the stability study period, there were no significant changes in the appearance, pH, or osmolality of any samples. The HPLC results also confirmed that the drug concentrations in all stability samples were within 98%-101% of the initial time zero values and no significant degradation product peaks were observed. Conclusion: A new compounded vancomycin eye drop formulation was developed to mitigate vehicle sourcing issues. This eye drop formulation was easy to prepare, exhibited satisfactory properties for ophthalmic applications, and remained stable chemically and physically when stored for 14 days in freezer followed by 28 days in refrigerator.

scholarly journals Stability and Compatibility of Diphenhydramine Hydrochloride in Intravenous Admixtures: A New Look at an Old Drug

2018 ◽  
Vol 54 (5) ◽  
pp. 330-334
Author(s):  
Daniel Sabins ◽  
Tuong Diep ◽  
Pamela McCartan ◽  
Shashi Patel ◽  
Fang Zhao
Keyword(s):  
Sodium Chloride ◽  
High Performance ◽  
Hplc Method ◽  
Stability Study ◽  
Limited Data ◽  
Diphenhydramine Hydrochloride ◽  
Drug Concentrations ◽  
The Stability ◽  
Initial Drug ◽  
Predetermined Time

Purpose: Intravenous (IV) admixtures of diphenhydramine are widely used in hospitalized patients to prevent or treat hypersensitivity reactions. However, there is limited data to support the admixture preparation in this manner. This study was designed to investigate the stability and compatibility of diphenhydramine in IV admixtures with a goal to establish a 14-day beyond-use dating with storage under refrigeration. Methods: The commercially available 50 mg/mL diphenhydramine hydrochloride injection vials were used to prepare the 0.2 and 1.0 mg/mL IV admixtures in 0.9% sodium chloride injection and 5% dextrose injection in 50 mL polyvinyl chloride (PVC) bags. The IV bags were sealed and stored under refrigeration (2°C-8°C) for the stability study. At each predetermined time point, samples were taken for visual inspection, pH measurement, and analysis by a stability-indicating high-performance liquid chromatography (HPLC) method. Results: The freshly prepared IV admixtures appeared clear, colorless, and particulate-free with pH readings of 4.44 to 4.60. The initial drug concentrations of all samples were confirmed by HPLC to be within 101.8% to 103.6% of the label claims. Over the 14 days of the study period, there was no significant change in the appearance or pH values for all stability samples. The HPLC results also confirmed that there was no more than ±2% change of the initial drug concentration in any stability samples. Conclusion: Diphenhydramine hydrochloride IV admixtures of 0.2 and 1.0 mg/mL are compatible with 0.9% sodium chloride injection and 5% dextrose injection in PVC bags. These IV admixtures are stable chemically and physically for up to 14 days when stored under refrigeration (2°C-8°C).

scholarly journals DEVELOPMENT AND VALIDATION OF STABILITY INDICATING RP-HPLC METHOD FOR DETERMINATION OF β-ACETYLDIGOXIN

2016 ◽  
Vol 9 (1) ◽  
pp. 54
Author(s):  
Megha Sharma ◽  
Neeraj Mahindroo
Keyword(s):  
High Performance ◽  
Degradation Products ◽  
Hplc Method ◽  
Stability Study ◽  
Array Detector ◽  
Forced Degradation ◽  
Simple Method ◽  
Stability Indicating ◽  
Rp Hplc

Objective: The objective of the present study was to develop and validate a novel stability indicating reverse phase-high performance liquid chromatography (RP-HPLC) method for determination of β-acetyldigoxin, an active pharmaceutical ingredient (API).Methods: The chromatographic separation was carried out on Agilent Technologies 1200 series HPLC system equipped with photo diode array detector and C-18 (4.6x250 mm, 5 µ) column. The mobile phase consisted of water: acetonitrile (65:35 v/v), delivered at a flow rate of 1.5 ml/min and eluents were monitored at 225 nm.Results: The retention time of β-acetyldigoxin was 9.2 min. The method was found to be linear (R2= 0.9995) in the range of 31.25-500 µg/ml. The accuracy studies showed the mean percent recovery of 101.02%. LOD and LOQ were observed to be 0.289 µg/ml and 0.965 µg/ml, respectively. The method was found to be robust and system suitability testing was also performed. Forced degradation analysis was carried out under acidic, alkaline, oxidative and photolytic stress conditions. Significant degradation was observed under tested conditions, except for oxidative condition. The method was able to separate all the degradation products within runtime of 20 min and was able to determine β-acetyldigoxin unequivocally in presence of degradation products.Conclusion: The novel, economic, rapid and simple method for analysis of β-acetyldigoxin is reported. The developed method is suitable for routine quality control and its determination as API, and in pharmaceutical formulations and stability study samples.

Development and Validation of RP-HPLC Method for Simultaneous Estimation of Gatifloxacin and flurbiprofen Sodium in Eye Drops

2019 ◽  
Vol 9 (01) ◽  
pp. 83-88
Author(s):  
Pinkal Patel ◽  
Nalini Patel ◽  
Kinjal Parmar
Keyword(s):  
High Performance ◽  
Pharmaceutical Formulations ◽  
High Performance Liquid Chromatographic ◽  
Reversed Phase ◽  
Hplc Method ◽  
Simultaneous Estimation ◽  
Eye Drops ◽  
Rp Hplc ◽  
Development And Validation ◽  
Liquid Chromatographic

A simple, selective and rapid reversed phase High Performance Liquid Chromatographic (RP-HPLC) method has been developed and validated for the simultaneous analysis Gatifloxacin and flurbiprofen sodium in eye drops. The separation was carried out using a mobile phase consisting ACN: Buffer (pH 3.5) in the ratio of 55:45 v/v. The column used was Phenomenex luna ODS C18 (250mm X 4.6 mm i.d., 5 μm particle size) with flow rate of 1 ml / min using UV detection at 268 nm. The described method was linear over a concentration range of 2-12 μg/ml for both of Gatifloxacin and flurbiprofen sodium. The retention times of Gatifloxacin and flurbiprofen sodium were found to be 3.710 min. and 6.797 min respectively. Method was validated statistically and recovery studies were carried out. The proposed method has been applied successfully to the analysis of cited drugs either in pure form or in pharmaceutical formulations with good accuracy and precision. The method here in described can be employed for quality control and routine analysis of drugs in pharmaceutical formulations.

scholarly journals BIO-ANALYTICAL METHOD DEVELOPMENT AND VALIDATION FOR SIMULTANEOUS DETERMINATION OF LEDIPASVIR AND SOFOSBUVIR DRUGS IN HUMAN PLASMA BY RP-HPLC METHOD

2018 ◽  
Vol 10 (3) ◽  
pp. 21 ◽  
Author(s):  
Buyya Shyam Sunder ◽  
Ashutosh Kumar Mittal
Keyword(s):  
Human Plasma ◽  
High Performance ◽  
Method Development ◽  
Hplc Method ◽  
Pharmacokinetic Studies ◽  
Buffer Solution ◽  
Stability Of Solution ◽  
Drug Concentrations ◽  
The Stability ◽  
Development And Validation

Objective: A novel, sensitive and accurate high-performance liquid chromatography with ultraviolet/visible light detection (HPLC-UV/VIS) method for the quantification of ledipasvir and Sofosbuvir in plasma was developed and validated. Methods: The analytes were extracted by liquid-liquid extraction method and chromatograph using a mobile phase consisting of acetonitrile and buffer solution, Methanol and Acetonitrile in the ratio of 200:600:200 (v/v) using Oyster BDS RP-C18 column. The flow rate 1.0 ml/min and UV detection at 238 nm were employed. The retention time for Ledipasvir and Sofosbuvir was 4.61 and 9.09 min respectively. Linearity for ledipasvir and Sofosbuvir was found to be in the range of 250-2000 ng/ml for both drugs respectively. Intra-and inter-day precision was less than 2% coefficient of variation.Results: The method was validated as per the USFDA guidelines and the results were within the acceptance criteria for selectivity, sensitivity, linearity, precision, accuracy, recovery stability of the solution, the stability of solution in plasma and dilution integrity.Conclusion: Majority of the HPLC method should be useful for monitoring human plasma drug concentrations, and pharmacokinetic studies in patients diagnosed with the Ledipasvir and Sofosbuvir formulations.

scholarly journals A Rapid Reversed-Phase HPLC Method for Analysis of Trans-Resveratrol in PLGA Nanoparticulate Formulation

2014 ◽  
Vol 2014 ◽  
pp. 1-6 ◽  
Author(s):  
Gurinder Singh ◽  
Roopa S. Pai
Keyword(s):  
High Performance ◽  
Linear Regression Analysis ◽  
Potassium Dihydrogen Phosphate ◽  
Plga Nanoparticles ◽  
Reversed Phase ◽  
Hplc Method ◽  
Dihydrogen Phosphate ◽  
Relative Standard ◽  
New Formulation

A rapid reversed-phase high performance liquid chromatography (RP-HPLC) method was developed for the determination of trans-resveratrol (t-RVT) in PLGA nanoparticle formulation. A new formulation of t-RVT loaded PLGA nanoparticles (NPs) with potential stealth properties was prepared by nanoprecipitation method in our laboratory. The desired chromatographic separation was achieved on a Phenomenex C18 column under isocratic conditions using UV detection at 306 nm. The optimized mobile phase consisted of a mixture of methanol: 10 mM potassium dihydrogen phosphate buffer (pH 6.8): acetonitrile (63 : 30 : 7, v/v/v) at a flow rate of 1 mL/min. The linear regression analysis for the calibration curves showed a good linear correlation over the concentration range of 0.025–2.0 μg/ml, with determination coefficients, R2, exceeding 0.9997. The method was shown to be specific, precise at the intraday and interday levels, as reflected by the relative standard deviation (RSD) values, lower than 5.0%, and accurate with bias not exceeding 15% and percentage recovery was found to be in the range between 94.5 and 101.2. The limits of detection and quantification were 0.002 and 0.007 μg/ml, respectively. The method was successfully applied for the determination of t-RVT encapsulation efficiency.

scholarly journals Physical and Chemical Stability of Dexamethasone Sodium Phosphate in Intravenous Admixtures Used to Prevent Chemotherapy-Induced Nausea and Vomiting

2019 ◽  
pp. 001857871988891
Author(s):  
Ina Buga ◽  
Joy I. Uzoma ◽  
Kristin Reindel ◽  
Kateryna Rashid ◽  
Tuong Diep ◽  
...  
Keyword(s):  
Sodium Chloride ◽  
High Performance ◽  
Sodium Phosphate ◽  
Room Temperature ◽  
Degradation Products ◽  
Storage Conditions ◽  
Hplc Method ◽  
Nausea And Vomiting ◽  
Dexamethasone Sodium Phosphate ◽  
Drug Concentrations

Purpose: Dilute intravenous (IV) admixtures of dexamethasone sodium phosphate (DSP) are becoming increasingly used in antiemetic regimens to prevent chemotherapy-induced nausea and vomiting (CINV). Based on its chemical structure and previous studies, DSP is known to be susceptible to hydrolysis and oxidation under certain conditions. There are limited data to directly support the selection of IV diluents, storage conditions, and beyond-use dates for the dilute IV solutions of DSP used in the antiemetic regimens. This study was designed to investigate these parameters. Methods: A stability-indicating high-performance liquid chromatography (HPLC) method was first developed for the analysis of DSP. Commercially available 100 mg/10 mL DSP injection vials were used to prepare the IV admixtures of DSP in 0.9% sodium chloride injection or 5% dextrose injection. The final DSP concentrations were 0.08 or 0.4 mg/mL, which bracketed the range commonly used in antiemetic regimens. These admixtures were packaged in 50-mL polyvinylchloride (PVC) bags and stored at room temperature or under refrigeration for 14 days. Samples from each IV bag underwent visual, pH, and HPLC assessments on days 0, 1, 3, 7, and 14. Results: Immediately after preparation, the IV admixtures of DSP appeared clear, colorless, and free of particulate matters. The initial pH values were 6.4 to 6.8 and 7.0 to 7.8 for samples in 0.9% sodium chloride and 5% dextrose, respectively. The initial DSP concentrations of all samples were within 96% to 100% of the expected values. Over the 14 days of storage at room temperature or refrigeration, no significant change was observed for the visual appearance of any IV bags. The pH of all samples remained within one pH unit from the initial values. The HPLC results confirmed that all samples retained 94% to 100% of original drug concentrations and that no significant degradation products were observed. Conclusions: Intravenous admixtures of DSP at 0.08 to 0.4 mg/mL are compatible with 0.9% sodium chloride and 5% dextrose in PVC bags. These admixtures are also chemically and physically stable when stored at room temperature or under refrigeration for up to 14 days.

scholarly journals Development and validation of HPLC method for analysis of dexamethasone acetate in microemulsions

2009 ◽  
Vol 45 (1) ◽  
pp. 87-92 ◽  
Author(s):  
Maria Cristina Cocenza Urban ◽  
Rubiana Mara Mainardes ◽  
Maria Palmira Daflon Gremião
Keyword(s):  
High Performance ◽  
Low Cost ◽  
Hplc Method ◽  
Good Precision ◽  
Standard Drug ◽  
Drug Concentrations ◽  
Analytical Curve ◽  
Relative Standard ◽  
Dexamethasone Acetate ◽  
Development And Validation

A simple, rapid, accurate and sensitive method was developed for quantitative analysis of dexamethasone acetate in microemulsions using high performance liquid chromatography (HPLC) with UV detection. The chromatography parameters were stainless steel Lichrospher 100 RP-18 column (250 mm x 4 mm i.d., 5 μm particle size), at 30 ± 2 ºC. The isocratic mobile phase was methanol:water (65:35; v/v) at a flow rate of at 1.0 mL.min-1. The determinations were performed using UV-Vis detector set at 239 nm. Samples were prepared with methanol and the volume injected was 20 μL. The analytical curve was linear (r² 0.9995) over a wide concentration range (2.0-30.0 μg.mL-1). The presence of components of the microemulsion did not interfere in the results of the analysis. The method showed adequate precision, with a relative standard deviation (RSD) smaller than 3%. The accuracy was analyzed by adding a standard drug and good recovery values were obtained for all drug concentrations used. The HPLC method developed in this study showed specificity and selectivity with linearity in the working range and good precision and accuracy, making it very suitable for quantification of dexamethasone in microemulsions. The analytical procedure is reliable and offers advantages in terms of speed and low cost of reagents.

scholarly journals Formulation and Stability Study of Omeprazole Oral Liquid Suspension for Pediatric Patients

2019 ◽  
Vol 55 (5) ◽  
pp. 314-322
Author(s):  
Oriana Boscolo ◽  
Francesco Perra ◽  
Leandro Salvo ◽  
Fabián Buontempo ◽  
Silvia Lucangioli
Keyword(s):  
High Performance ◽  
Pediatric Patients ◽  
Hplc Method ◽  
Stability Study ◽  
Oral Formulations ◽  
Liquid Suspension ◽  
Oral Liquid ◽  
Microbiological Stability ◽  
Pediatric Use ◽  
Liquid Suspensions

Objectives: To develop and to study the physicochemical and microbiological stability of omeprazole liquid oral formulations used as therapeutic agent in many acid-related disorders, for pediatric use. Furthermore, to optimize and validate a stability-indicating high-performance liquid chromatography (HPLC) method for the analysis of omeprazole in the studied formulations. Method: Oral liquid suspensions of omeprazole were prepared at 2 mg/mL using crushed omeprazole pellets (formulation A) and pure omeprazole (formulation B) with a complete vehicle including humectant, suspending, sweetening, antioxidant, and flavoring agents. Samples were stored at 4°C and 25°C. Omeprazole content of each formulation was analyzed in triplicate using micro-HPLC at 0, 3, 7, 14, 30, 60, 90, 120, and 150 days. Other parameters were also determined, such as appearance, pH, resuspendibility, and viscosity. Microbiological studies were conducted according to the United Stated Pharmacopeia (USP) guidelines for non-sterile products. Results: Formulation A stayed physicochemical and microbiologically stable at refrigerated (4°C) conditions during at least 150 days and it only stayed stable during 14 days at 25°C. Formulation B was stayed physicochemical and microbiologically stable at refrigerated (4°C) conditions at least 90 days, but it is not recommended to store at 25°C for more than 1 day. Conclusions: Formulation A and formulation B can be stored for at least 150 and 90 days, respectively, at refrigerated conditions. Formulation A can be stored at room temperature for 14 days. Both formulations are perfectly suitable for pediatric patients who are usually notable to swallow solid oral formulations. The proposed analytical method was suitable for the study of stability of different formulations.

scholarly journals Pharmacokinetic comparisons of S-oxiracetam and R-oxiracetam in beagle dogs

2016 ◽  
Vol 66 (2) ◽  
pp. 279-287 ◽  
Author(s):  
Wusan Wang ◽  
Hui Ji ◽  
Tingting Li ◽  
Yuanwei Jia ◽  
Haitang Xie
Keyword(s):  
High Performance ◽  
Conformational Stability ◽  
High Performance Liquid Chromatographic ◽  
Hplc Method ◽  
Stability Study ◽  
Normal Phase ◽  
Pharmacokinetic Analysis ◽  
Beagle Dogs ◽  
Random Crossover ◽  
Liquid Chromatographic

Abstract A pharmacokinetic comparison and conformational stability study of S-oxiracetam (S-ORT) and R-oxiracetam (R-ORT) in beagle dogs was used to investigate the possible mechanism of different effects of two oxiracetam enantiomers through a random crossover design. After drug administration to beagle dogs, blood samples were collected at different time points for pharmacokinetic analysis using the UPLC-ESI-MS/MS method. Parts of plasma samples were used for conformation transformation studies using a normal phase high performance liquid chromatographic (NP HPLC) method. The study showed that oxiracetam enantiomers maintained their original conformation when administered orally to beagle dogs. Concentrations of S-ORT were significantly higher than R-ORT 1.5 and 2 h after administration; the AUC0-∞ of S-ORT after oral administration tended to be higher than that of R-ORT, which showed that the different effects between S-ORT and R-ORT may be partly associated with their distinctive absorption at least.

scholarly journals Concentrations of Pefloxacin in Plasma and Tissue after Administration as Surgical Prophylaxis

1998 ◽  
Vol 42 (2) ◽  
pp. 425-427 ◽  
Author(s):  
Bernadette Jacoberger ◽  
Genevieve Ubeaud ◽  
Guy Freys ◽  
Thierry Pottecher ◽  
Louis Jung ◽  
...  
Keyword(s):  
High Performance Liquid Chromatography ◽  
Liquid Chromatography ◽  
Colorectal Surgery ◽  
High Performance ◽  
Antimicrobial Prophylaxis ◽  
Surgical Prophylaxis ◽  
Drug Concentrations ◽  
Low Concentrations ◽  
The Family

ABSTRACT Plasma and epiploic-fat drug concentrations determined by high-performance liquid chromatography and fat penetration of pefloxacin and its metabolite (norfloxacin) given for antimicrobial prophylaxis were studied in patients scheduled for colorectal surgery. Concentrations of pefloxacin in plasma decreased about 40% from the beginning of the operation to closure of the peritoneum, and corresponding levels in epiploic fat stayed stable. The plasma and tissue norfloxacin concentrations were very low. Concentrations of pefloxacin in tissue were greater than MIC at which 90% of isolates are inhibited for sensitive bacteria (members of the familyEnterobacteriaceae). The penetration of pefloxacin into epiploic fat was about 32%.

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