Stability of Ziprasidone Mesylate in an Extemporaneously Compounded Oral Solution

2010 ◽  
Vol 15 (2) ◽  
pp. 138-141
Author(s):  
Kelsey Green ◽  
Roy C. Parish
Keyword(s):  
High Performance ◽  
Room Temperature ◽  
Physical Stability ◽  
Storage Condition ◽  
High Performance Liquid Chromatographic ◽  
Oral Solution ◽  
Fluorescent Light ◽  
Light Illumination ◽  
Liquid Preparation ◽  
Liquid Chromatographic

ABSTRACT OBJECTIVES To formulate a liquid preparation of ziprasidone in a convenient concentration to allow dosing of less than 20 mg and of sufficient chemical and physical stability to enable an entire prescription or course of treatment to be prepared in a single batch. METHODS Geodon for injection (ziprasidone mesylate), 20 mg/mL, was diluted to 2.5 mg/mL in a commercially available sugar-free and alcohol-free, flavored syrup and stored at room temperature under ambient fluorescent light illumination, at room temperature in darkness, and under refrigeration. The ziprasidone content was measured in samples at various time intervals using a stability-indicating high-performance liquid chromatographic method. RESULTS When refrigerated, the ziprasidone syrup that was compounded in a commercially available, sugar-free and alcohol-free vehicle maintained at least 90% of stated potency for at least 6 weeks. Samples stored under other conditions were less stable, underscoring the manufacturer's labeling regarding refrigerated storage of the reconstituted injection. CONCLUSIONS The findings suggest that chemical and physical stability are maintained for 2 weeks under refrigeration, allowing the convenience of compounding for the long-term needs of a particular patient, rather than daily compounding. The only storage condition we recommend is refrigeration at 5°C.

scholarly journals Phytochemical Profile of Opuntia ficus-indica (L.) Mill Fruits (cv. ‘Orito’) Stored at Different Conditions

Foods ◽  
2022 ◽  
Vol 11 (2) ◽  
pp. 160
Author(s):  
Francisca Hernández ◽  
Lucía Andreu-Coll ◽  
Andreia Bento-Silva ◽  
Ana Teresa Serra ◽  
Pedro Mena ◽  
...  
Keyword(s):  
Shelf Life ◽  
Cold Storage ◽  
Product Life Cycle ◽  
High Performance ◽  
Room Temperature ◽  
Phenylalanine Ammonia Lyase ◽  
High Performance Liquid Chromatographic ◽  
Array Detector ◽  
Phytochemical Profile ◽  
Liquid Chromatographic

This research analyzed the phytochemical profile of prickly pear fruits from ‘Orito’ cultivar stored under cold conditions (2 °C, 85–90% RH) and shelf-life conditions at room temperature (stored at 20 °C for three days after cold storage) for 28 days, mimicking the product life cycle. A total of 18 compounds were identified and quantitated through HPLC-DAD-MS/MS (High-Performance Liquid Chromatographic -Diode Array Detector- Mass Spectrometry) analyses. Phenolic acids such as eucomic acid and betalains such as indicaxanthin were the predominant chemical families, and piscidic acid was the most abundant compound. During cold storage, the content of eucomic acid isomer/derivative and syringaresinol increased, and citric acid decreased, which could be caused by the cold activation of the phenylalanine ammonia-lyase (PAL) and polyphenol oxidase (PPO) enzymes. However, no significant differences were found in the content of these compounds during shelf-life storage. These results showed that ‘Orito’ fruit marketability would be possible up to 28 days after harvesting, retaining its profile, which is rich in bioactive compounds.

scholarly journals Stability Assessment of Cephradine Suspension Formulated in Bangladesh

2011 ◽  
Vol 3 (2) ◽  
pp. 383-391
Author(s):  
M. Z. Sultan ◽  
M. A. Mazid ◽  
M. A. Rashid
Keyword(s):  
Aqueous Medium ◽  
High Performance ◽  
Room Temperature ◽  
Chromatographic Method ◽  
Pharmaceutical Preparation ◽  
High Performance Liquid Chromatographic ◽  
Reversed Phase ◽  
Sodium Phosphate Buffer ◽  
The Stability ◽  
Liquid Chromatographic

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)

Stability of Olmesartan Medoxomil Extemporaneous Suspensions

2021 ◽  
pp. 875512252110517
Author(s):  
Prapanna Bhattarai ◽  
Timothy McPherson ◽  
Marcelo Nieto ◽  
William M. Kolling
Keyword(s):  
United States ◽  
High Performance ◽  
Room Temperature ◽  
Physical Stability ◽  
Olmesartan Medoxomil ◽  
Storage Condition ◽  
The United States ◽  
Priority List ◽  
Study Results ◽  
Stability Data

Background: Olmesartan medoxomil (OLM) is only available in the United States as tablets. The United States Pharmacopoeia (USP) has placed OLM on its priority list of preparations that require stability data to support practitioner compounding. Objective: The purpose of the study was to develop a stability-indicating assay and then determine the beyond-use date (BUD) for an extemporaneous OLM suspension. Methods: A reverse-phase high-performance liquid chromatography (HPLC) assay was developed and validated according to guidelines for USP official compounded monographs. OLM 2 mg/mL suspensions were compounded with Ora-Sweet and Ora-Plus and stored at room temperature or in a refrigerator. Suspensions were assayed periodically over 90 days for OLM concentration and observed for physical stability. The pH was measured at the beginning and end of the study. Results: The OLM concentration remained above 97% of the starting concentration for 90 days when stored in the refrigerator and above 94% of the starting concentration for 90 days when stored at room temperature. The suspension pH did not change and indicators of physical stability were unchanged for 90 days. Conclusion: OLM 2 mg/mL suspensions were chemically and physically stable at room temperature and in the refrigerator for 90 days. The BUD may be set at 90 days under either storage condition.

scholarly journals Stability-Indicating High-Performance Liquid Chromatographic Determination of Levamisole Hydrochloride in Bulk and Dosage Forms

2020 ◽  
Vol 2020 ◽  
pp. 1-8
Author(s):  
Amal Abdalraheem ◽  
Shaza Shantier ◽  
Imad Abureid ◽  
Elrasheed A. Gadkariem
Keyword(s):  
High Performance ◽  
Limit Of Detection ◽  
Chromatographic Determination ◽  
High Performance Liquid Chromatographic ◽  
Hplc Method ◽  
Oral Solution ◽  
Official Method ◽  
Stability Indicating ◽  
Limit Of Quantitation ◽  
Liquid Chromatographic

A selective, accurate, and precise stability-indicating HPLC method for analysis of levamisole hydrochloride in bulk and in their injection and oral solution formulations has been developed and validated in accordance with ICH guidelines. The chromatographic separation was carried out on a C8 column (250 × 4.6 mm with a particle size of 5 micrometer) using a mixture of phosphate buffer pH 8.0 and acetonitrile (70 : 30 v/v) as the mobile phase pumped at a flow rate of 1.5 ml/min with UV detection at 215 nm. The calibration curve was linear over the 10–50 μg/ml concentration range with a correlation coefficient of 1.0000. The limit of detection (LOD) and the limit of quantitation (LOQ) were 0.29 μg/ml and 0.89 μg/ml, respectively. The accuracy and the precision of the developed method were significantly good (RSD < 2%). The validity of the proposed method was further confirmed through the statistical comparison of the obtained data with those of the official method.

scholarly journals Development and Validation of Estimation of Genotoxic Impurity (Benzimidamidecontent) in Leflunomide by Using RP-HPLC Technique

2021 ◽  
pp. 78-85
Author(s):  
Mohan Bhatale ◽  
Neelakandan Kaliyaperumal ◽  
Gopalakrishnan Mannathusamy ◽  
Gurunathan Ramalingam
Keyword(s):  
High Performance ◽  
Room Temperature ◽  
High Performance Liquid Chromatographic ◽  
Hplc Method ◽  
Reverse Phase ◽  
Intermediate Precision ◽  
Rp Hplc ◽  
Development And Validation ◽  
Liquid Chromatographic ◽  
Program Mode

The measurement of Genotoxic contaminant, a simple, selective, linear, accurate, and specific reverse phase high-performance liquid chromatographic (RP-HPLC) process was proposed. A Benzimidamide impurity in the medication Leflunomide has been discovered. Separation and analysis were carried out on Zorbax SB phenyl (4.6 mm x 250 mm) with a particle size of 5.0 μm. with 0.1 % Triethylamine in purified water with a pH of 7.0 and a buffer of phosphoric acid (20% in water). The mobile phase is a 40:60 mixture of buffer and Acetonitrile with degassing. Isocratic program mode was used. The elution was carried out at a rate of 1.0 mL/min with UV detection at a wavelength of 289 nm. The temperature of the selected column oven is 25°C. The linearity and accuracy of Benzimidamide are covered in this approach, with a LOQ limit of 150 percent (i.e.0.03 to 0.45 ppm). The observed correlation coefficient is 0.99994, with a range of 100.01 to 104.8 for recovery. The measured percent RSD of six spiked test preparation is below 5.0 percent in procedure precision (i.e. repeatability) and intermediate precision (IP). When maintained at room temperature, the standard and sample remained stable for three days. System appropriateness characteristics such as tailing factor and percent RSD do not exhibit significant changes in robustness experiments. For the detection of Benzimidamide the present RP-HPLC method is act as selective, robust, linear and precise.

High Performance Liquid Chromatographic Determination of Vitamin D in Fortified Milks, Margarine, and Infant Formulas

1982 ◽  
Vol 65 (3) ◽  
pp. 624-631 ◽  
Author(s):  
James N Thompson ◽  
George Hatina ◽  
William B Maxwell ◽  
Suzanne Duval
Keyword(s):  
Vitamin D ◽  
High Performance ◽  
Room Temperature ◽  
Chromatographic Determination ◽  
Solvent System ◽  
High Performance Liquid Chromatographic ◽  
Coefficients Of Variation ◽  
Liquid Chromatographic Determination ◽  
Liquid Chromatographic

Abstract Fortified milks were saponified overnight at room temperature with 1% ethanolic pyrogallol and KOH. The digest was extracted with hexane after adding water and ethanol, and the extract was washed consecutively with 5% KOH, water, and 55% aqueous ethanol to remove polar lipids. After evaporation, the residue was first chromatographed on a column of 5 μm silica. A fraction containing vitamin D was collected, evaporated, and rechromatographed on a reverse phase column for the separation and quantitation of vitamins D2 and D3. Recovery was 96-99% and the coefficient of variation was 3% (8 replicates). Infant formula was diluted and then saponified and extracted as in the analysis of milk. Margarine was saponified by shaking overnight with 1% ethanolic pyrogallol and 80% KOH. Water and ethanol were added to the digest before extraction. Extracts from formula and margarine were chromatographed as milk except, before HPLC, the extract was dissolved in isopropanol-hexane (1 + 99) and passed through 5 cm alumina in a Pasteur pipet, and the concentration of isopropanol in the first high performance liquid chromatographic (HPLC) solvent system was halved to improve the separation of vitamin D from other absorbing lipids. Usually several peaks were obtained during the final HPLC analysis, and the identification of vitamins D2 and D3 was less certain than in the analysis of milk. The coefficients of variation for formula and margarine were 6% (5 replicates) and 9% (6 replicates), respectively.

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