Stability of a pyrimethamine suspension compounded from bulk powder

2017 ◽  
Vol 74 (24) ◽  
pp. 2060-2064 ◽  
Author(s):  
Paul O. Lewis ◽  
David B. Cluck ◽  
Jessica D. Huffman ◽  
Amanda P. Ogle ◽  
Stacy D. Brown
Keyword(s):  
High Performance ◽  
Room Temperature ◽  
Hplc Method ◽  
Stability Indicating ◽  
Color Changes ◽  
Stability Indicating Method ◽  
Bulk Powder ◽  
Subsequent Application ◽  
Temperature Ranges ◽  
The Stability

Abstract Purpose Development of a stability-indicating high-performance liquid chromatography (HPLC) method for pyrimethamine analysis, with subsequent application of that method to assess the 90-day stability of a pyrimethamine suspension compounded from bulk USP-grade pyrimethamine powder, is described. Methods A stability-indicating method of HPLC with ultraviolet detection specific to pyrimethamine was developed according to pharmacopeial recommendations and validated. The method was applied to investigate the stability of a 2-mg/mL pyrimethamine suspension in a vehicle consisting of Ora-Plus and Ora-Sweet (Perrigo) over a period of 90 days. Three replicate test preparations were stored at room temperature or refrigerated at 4.3–5.2 °C, and samples were analyzed in duplicate immediately after preparation and on study days 1, 2, 4, 7, 10, 14, 21, 30, 48, 60, 75, and 90. Results The 2-mg/mL suspension of pyrimethamine in Ora-Plus and Ora-Sweet retained 90–110% of the labeled potency to 90 days at both temperature ranges. However, color changes in the samples stored at room temperature observed at day 60 indicated that a beyond-use date less than 90 days from the preparation date should be specified when the suspension is to be stored at room temperature. Conclusion The study demonstrated that USP-grade pyrimethamine powder can be formulated as a 2-mg/mL suspension in a vehicle of Ora-Plus and Ora-Sweet and is stable when stored at room temperature and when refrigerated, in amber plastic bottles, for 48 and 90 days, respectively.

Stability-indicating HPLC method to determine the stability of extemporaneously prepared vancomycin oral solution cups

2021 ◽  
Author(s):  
Ankit Rochani ◽  
Vinh Nguyen ◽  
Robin Becker ◽  
Gagan Kaushal
Keyword(s):  
Relative Humidity ◽  
High Performance ◽  
Room Temperature ◽  
Hplc Method ◽  
Oral Solution ◽  
Hplc Assay ◽  
Stability Indicating ◽  
Oral Formulations ◽  
Unit Dose ◽  
The Stability

Abstract Purpose To determine the stability of compounded sweetened vancomycin oral formulations in plastic unit dose cups stored up to 180 days under 2 temperature conditions: refrigeration (2°C-6°C) and room temperature (25°C with 60% relative humidity). Methodology A stability-indicating high-performance liquid chromatography (HPLC) method was developed to analyze vancomycin in the presence of degradation peaks. The stability of extemporaneously compounded vancomycin solution stored in oral unit dose cups was investigated using this method. The tested vancomycin oral solutions were compounded formulations of 125 mg/2.5 mL and 500 mg/10 mL. Three oral unit dose cups from each storage condition were withdrawn and assessed for stability on days 0, 3, 7, 15, 22, 30, 90, 120, 150, and 180 as per United States Pharmacopeia guidelines. The assay of vancomycin was carried out by using a calibrated stability-indicating HPLC method. Results The stability-indicating HPLC assay showed that vancomycin completely degraded within 2 hours when exposed to highly acidic or basic pH conditions. No precipitation, cloudiness, or color changes were observed during the study under either temperature condition. The HPLC assay revealed that vancomycin oral solution cups retained greater than 90% of the initial concentrations of vancomycin for 30 days when stored at room temperature (25°C and 60% relative humidity) and for 180 days with refrigeration (2°C-6°C). Conclusion Vancomycin oral formulations were stable for long-term storage periods beyond those specified in manufacture guidelines. Our data suggests the extended stability of vancomycin oral solutions compounded for hospital use can be extended.

scholarly journals Physicochemical Stability of 5 mg/mL Pediatric Prednisone Oral Suspension in Syrspend® SF PH4

2018 ◽  
Vol 0 (0) ◽  
Author(s):  
Anne-Claire Bonnaure ◽  
Romain Bellay ◽  
Pauline Rault ◽  
Marie-Antoinette Lester ◽  
Pierre-Nicolas Boivin
Keyword(s):  
Degradation Product ◽  
Sodium Benzoate ◽  
High Performance ◽  
Room Temperature ◽  
Inflammatory Diseases ◽  
Oral Suspension ◽  
Stability Indicating Method ◽  
Physicochemical Stability ◽  
The Stability ◽  
Physical And Chemical

Abstract Background Prednisone is a corticosteroid used in several inflammatory diseases and cancers. In France, no available prednisone drinkable formulation exists. Instead, an oral syrup of prednisone with ethanol, sodium benzoate and simple syrup is produced. However, sodium benzoate can induce neonatal icterus and alcohol is not authorized for children below 3 years of age. The aim of this study was to determine the stability of 5 mg/mL prednisone oral suspension in a commercial compounding excipient: Syrspend® SF PH4. Methods Three batches of oral suspensions were prepared, using micronized prednisone and Syrspend® SF PH4. They were packaged in amber glass vials and stored at room temperature. On day 0, 1, 4, 10, 30, 60 and 90, we observed physical and chemical stability (pH measurement, osmolality measurement, residual concentrations of prednisone and degradation product identification). A stability indicating method was developed using high performance liquid chromatography with Ultraviolet detection at 254 nm. Results Prednisone concentrations remained stable within ± 5 % of nominal values for 60 days. No degradation product and change of physicochemical properties were detected. Conclusion This study showed that 5 mg/mL prednisone oral suspension in Syrspend® SF PH4 is stable for 60 days, at room temperature and protected from light.

scholarly journals Stability-indicating LC-MS Method for Determination of Stability of Extemporaneously Compounded Buprenorphine Oral Syringes for Neonatal Abstinence Syndrome

2021 ◽  
Vol 26 (4) ◽  
pp. 395-404
Author(s):  
Ankit Rochani ◽  
Vinh Nguyen ◽  
Robin Becker ◽  
Walter Kraft ◽  
Gagan Kaushal
Keyword(s):  
High Performance ◽  
Room Temperature ◽  
Color Change ◽  
Storage Condition ◽  
Stability Study ◽  
Neonatal Abstinence Syndrome ◽  
Limited Information ◽  
Abstinence Syndrome ◽  
Stability Indicating ◽  
The Stability

OBJECTIVE In the hospital settings, buprenorphine is used for the treatment of patients with neonatal abstinence syndrome. It is extemporaneously compounded and stored in oral plastic syringes. However, limited information exists about the stability of buprenorphine and its compounded formulations when stored under specific conditions. Hence, we developed a stability-indicating high-performance liquid chromatography–mass spectrometry (LC-MS) method to analyze the stability of buprenorphine over time. METHODS A stability-indicating LC-MS method was developed to map the potential degradation peaks of buprenorphine when exposed to acidic, basic, and oxidative conditions. This method was used to study the stability of compounded buprenorphine oral syringes stored under refrigeration (2°C–8°C) and room temperature (25°C ± 2°C with 60% relative humidity). Syringes from each storage condition were assessed for stability using pH meter and stability-indicating LC-MS assay for 30 days. RESULTS Buprenorphine gets completely degraded in the presence of acid at the end of 1 hour of exposure. Various degradation peaks were identified using LC-MS assay for buprenorphine under acidic, basic, and peroxide conditions. Stability study of oral buprenorphine syringes showed no precipitation, cloudiness, or color change during this study at all storage conditions. The LC-MS assay revealed that buprenorphine oral syringes retained greater than 90% of the initial concentrations for 30 days. CONCLUSIONS Highly sensitive stability-indicating LC-MS method was developed for studying the stability of extemporaneously compounded buprenorphine oral syringes. This study demonstrates that buprenorphine extemporaneous formulation prepared according to the manufacturers' recommendations is stable under refrigerated or room temperature conditions for 30 days in oral plastic syringes.

scholarly journals Evaluation of degradation kinetics for abamectin in formulations using a stability indicating method

2013 ◽  
Vol 63 (1) ◽  
pp. 59-69 ◽  
Author(s):  
Atul Awasthi ◽  
Majid Razzak ◽  
Raida Al-Kassas ◽  
Joanne Harvey ◽  
Sanjay Garg
Keyword(s):  
Degradation Kinetics ◽  
Hplc Method ◽  
Degradation Behavior ◽  
Ph Change ◽  
Stability Indicating ◽  
First Order ◽  
Stability Indicating Method ◽  
First Order Kinetics ◽  
Maximum Stability ◽  
The Stability

The aim of this study was to evaluate stability characteristics and kinetics behavior of abamectin (ABM) as a 1 % (m/V) topical veterinary solution. During the study, samples stressed at 55 and 70 °C were regularly analyzed for several parameters over 8 weeks on a chromatographic (HPLC) system, using a Prodigy C18, 250 x 4.6 mm, 5-μm, column eluting with 15 : 34 : 51 (V/V/V) water/methanol/ acetonitrile as mobile phase. The HPLC method was validated for precision, accuracy, linearity and specificity, and was found to be stability indicating. The results showed that degradation of ABM followed first-order kinetics and data on loss in kobs (s-1) and half life (t1/2, days) demonstrated ABM showing the maximum stability in glycerol formal. The degradation behavior of ABM varies from solvent to solvent. The effect of added alkali on pH change and loss of ABM was studied and found to be unique for all solvents and very distinct from typical hydrolysis degradation. The present study may serve as a platform to design and develop topical non-aqueous solutions of ABM for veterinary use given no such comprehensive efforts have been published to date on the stability profile of ABM in non-aqueous solvents.

Development and Validation of a Stability Indicating RP-HPLC Method for Hydrocortisone Acetate Active Ingredient, Propyl Parahydroxybenzoate and Methyl Parahydroxybenzoate Preservatives, Butylhydroxyanisole Antioxidant, and Their Degradation Products in a Rectal Gel Formulation

2015 ◽  
Vol 98 (1) ◽  
pp. 27-34 ◽  
Author(s):  
Magda Ascaso ◽  
Pilar Pérez-Lozano ◽  
Mireia García ◽  
Encarna García-Montoya ◽  
Montse Miñarro ◽  
...  
Keyword(s):  
Active Ingredient ◽  
Active Substance ◽  
Degradation Products ◽  
Gradient Elution ◽  
Hplc Method ◽  
Array Detector ◽  
Hydrocortisone Acetate ◽  
Stability Indicating ◽  
Stability Indicating Method ◽  
The Stability

Abstract A stability indicating method was established through a stress study, wherein different methods of degradation (oxidation, hydrolysis, photolysis, and temperature) were studied simultaneously to determine the active ingredient hydrocortisone acetate, preservatives propyl parahydroxybenzoate, and methyl parahydroxybenzoate, antioxidant butylhydroxyanisole (BHA), and their degradation products in a semisolid dosage gel form. The proposed method was suitably validated using a Zorbax SB-Phenyl column and gradient elution. The mobile phase consisted of a mixture of methanol, acetonitrile, and water in different proportions according to a planned program at a flow rate of 1.5 mL/min. The diode array detector was set at 240 nm for the active substance and two preservatives,and 290 nm for BHA. The validation study was conducted according to International Conference on Harmonization guidelines for specificity, linearity, repeatability, precision, and accuracy. The method was usedfor QC of hydrocortisone acetate gel and for the stability studies with the aim of quantifying the active substance, preservatives, antioxidant, and degradation products. It has proved to be suitable as a fast and reliable method for QC.

scholarly journals A SIMULTANEOUS ESTIMATION, VALIDATION AND FORCED DEGRADATION STUDIES OF 5-FLUOROURACIL AND TEGAFUR IN A PHARMACEUTICAL DOSAGE FORM USING REVERSED-PHASE HIGH-PERFORMANCE LIQUID CHROMATOGRAPHY METHOD

2018 ◽  
Vol 11 (12) ◽  
pp. 132
Author(s):  
Vaishali Mistry ◽  
Akshay Yelwe ◽  
Amey Deshpande
Keyword(s):  
High Performance Liquid Chromatography ◽  
Liquid Chromatography ◽  
High Performance ◽  
Reversed Phase ◽  
Hplc Method ◽  
Simultaneous Estimation ◽  
Uv Detector ◽  
Stability Indicating ◽  
Rp Hplc ◽  
The Stability

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.

scholarly journals Stability-Indicating HPLC Method for isoflavones aglycones analysis from Trifolium pratense L. extract

2020 ◽  
Vol 4 (1) ◽  
pp. 28-38
Author(s):  
Simony Martiny ◽  
Mairique Waszczuk ◽  
Samuel Kaiser ◽  
Marina Cardoso Nemitz ◽  
Valquiria Linck Bassani
Keyword(s):  
Hplc Analysis ◽  
Trifolium Pratense ◽  
Degradation Products ◽  
Hplc Method ◽  
Alkaline Media ◽  
Biochanin A ◽  
Forced Degradation ◽  
Stability Indicating ◽  
Stability Indicating Method ◽  
The Stability

The purpose of this study was to develop and validate a fast HPLC stability-indicating method for simultaneously quantifying the four main isoflavones in Trifolium pratense. Validation procedures followed the ICH requirements for complex matrices. The stability-indicating tests were performed by exposing the isoflavones to conditions of forced degradation and further analysis for verifying the formation of degradation products and their possible interferences in the HPLC analysis. The major isoflavones of Trifolium pratense proved to be stable against acid and oxidative media, thermodegradation, and photodegradation. However, they proved to be unstable in alkaline media, even for short periods of exposure like 2h. In this condition, in addition to the peaks corresponding to isoflavones, the HPLC analysis showed the presence of three additional peaks which were eluted at different retention times to the reference substances, without interfering in the quantification of the four analytes of interest, formononetin, biochanin A, daidzein and genistein. The method was validated following ICH guidelines showing to be specific, linear, precise, accurate, and robust.This first report concerning a stability-indicating method revealed that the proposed HPLC method reliably quantify the isoflavones and separate them from the degradation products in a short time of analysis.

Validated stability indicating HPLC method to quantify lamivudine and dolutegravir in tablets

2020 ◽  
Vol 11 (4) ◽  
pp. 5082-5088
Author(s):  
Rama Kumar Kandula ◽  
Raja Sundararajan
Keyword(s):  
Limit Of Detection ◽  
Hplc Method ◽  
Array Detector ◽  
Limit Of Quantification ◽  
Method Performance ◽  
Therapy Regimen ◽  
Stability Indicating ◽  
Stability Indicating Method ◽  
Relative Standard ◽  
The Stability

Dovato tablets (lamivudine and dolutegravir combination) are full therapy regimen for the Type 1 human immunodeficiency virus (HIV-1) infection in adults without history of antiretroviral therapy. The aim of present research focused on development of validated stability indicating method for the quantification of lamivudine and dolutegravir in combined dosage form.The separation was achieved on a Cosmicsil C18 column. The mobile phase consisted of 0.1% orthophosphoric acid (pH 3.5) – acetonitrile (50:50, v/v). Photodiode array detector was used to detect the analytes at 258 nm. The method performance was validated in compliance with the recommendations of the International Conference on Harmonization.The method was validated with selectivity, limit of detection (0.262 μg/ml for lamivudine and 0.238 μg/ml for dolutegravir), linearity (150-450 μg/ml for lamivudine and 25-75 μg/ml for dolutegravir), limit of quantification (0.874 μg/ml for lamivudine and 0.793 μg/ml for dolutegravir), accuracy (percent recovery was nearer to 100%), precision (percent relative standard deviation was less than 2.0%) and robustness (system suitability values are within limits). The stability indicating method was performed by under the various stress conditions. Degradants did not interfere with lamivudine and dolutegravir detection. The developed method can suggest that quantification of lamivudine and dolutegravir in quality control of analytical laboratories.

scholarly journals Development and Validation of a Novel Stability-Indicating Reversed-Phase High-Performance Liquid Chromatography Method for Assay of Loratadine and Determination of Its Related Compounds

2010 ◽  
Vol 93 (3) ◽  
pp. 891-903 ◽  
Author(s):  
Jun Lu ◽  
Yu-Chien Wei ◽  
Robert J Markovich ◽  
Abu M Rustum
Keyword(s):  
High Performance ◽  
Sodium Dodecyl ◽  
Active Pharmaceutical Ingredient ◽  
Reversed Phase ◽  
Hplc Method ◽  
Chromatography Method ◽  
Stability Indicating ◽  
The Stability ◽  
Related Compounds

Abstract Loratadine is an important active pharmaceutical ingredient used in a wide variety of prescription and over-the-counter products for the treatment and relief of allergy symptoms. A novel stability-indicating gradient ion-pair RP-HPLC method for assay of loratadine and determination of both of its degradation compounds and process impurities has been developed. This method can separate loratadine from its eight structurally related compounds; it can also separate all of the related compounds from each other in less than 20 min. The stability-indicating capability of this method has been demonstrated by analyzing aged stability samples of loratadine. A 15 cm 4.6 mm id YMC-Pack Pro C18 HPLC column was the primary column and a 15 cm 4.6 mm id SunFire C18 column has been identified as an alternate (truly equivalent) column for this method. This gradient method uses mobile phases consisting of acetonitrile and an aqueous solution of 10 mM sodium acetate and 5 mM sodium dodecyl sulfate at pH 5.5. The new HPLC method was validated according to International Conference on Harmonization guidelines and proved to be suitable for routine QC use.

scholarly journals Development of stability indicating method for quality assessment of African Albendazole tablets

2021 ◽  
Vol 319 ◽  
pp. 01084
Author(s):  
Amine Hssaine ◽  
Miloud El Karbane ◽  
Mohamed Azougagh ◽  
Imad Eddine Houti ◽  
Brahim Benaji
Keyword(s):  
Gradient Elution ◽  
The United States ◽  
Hplc Method ◽  
Stability Indicating ◽  
Stability Indicating Method ◽  
The Stability ◽  
Physical And Chemical ◽  
States Pharmacopeia

In order to assess the quality of Albendazole tablets (Alb) sampled in three countries from West Africa, several physical and chemical tests were performed on tablets at normal conditions. A simple and economic HPLC method has been developed, validated and used for the simultaneous determination of Albendazole (Alb) content, as well as its impurities and the uniformity of its content. The stability-indicating HPLC method was performed on a Symmetry C18-5µm 250 mm × 4.6 mm column with a gradient elution using a mobile phase composed of acetonitrile and sodium acetate buffer. The flow rate was set at 1 mL.min−1 and the eluent was monitored at 295nm. The method was validated for specificity, linearity, accuracy, precision, robustness and detection and quantification limits, in accordance with International Conference on Harmonisation Quality 2 (ICH Q2) guidelines. This method was performed on different Alb samples (originals and generics) products collected from Senegal, Niger and Mali. The obtained results showed that, the contents of the generic tablets from Niger and Mali comply with the United States Pharmacopeia (USP) monograph acceptance criteria. However, more than 20% of the generic tablets don’t meet the USP monograph impurity limits. In conclusion, the described analytical method is simple, sensitive and accurate. Thus, it could be useful for manufacturing and quality control assays.

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