Effect of Preparation Method and Storage on Rifampin Concentration in Suspensions

1994 ◽  
Vol 28 (2) ◽  
pp. 182-185 ◽  
Author(s):  
Milap C. Nahata ◽  
Richard S. Morosco ◽  
Thomas F. Hipple
Keyword(s):  
Storage Time ◽  
Solution Method ◽  
Preparation Method ◽  
Hplc Method ◽  
Measured Concentration ◽  
Preparation Methods ◽  
Initial Concentration ◽  
Stability Indicating ◽  
The Mean ◽  
And Storage

OBJECTIVE: To determine the effect of four preparation methods and extended storage on rifampin concentration in extemporaneously prepared suspensions. DESIGN: Four preparation methods were used: mixing intravenous (iv) rifampin in syrup (A); manufacturer's recommended technique of mixing capsule (Rifadin) contents in syrup (B); triturating capsule contents in syrup into a paste and adding remaining syrup while mixing (C); and triturating capsule contents in syrup into a paste, adding syrup, retriturating the slurry, and adding remaining syrup while mixing (D). Samples were drawn from each of five bottles of each of the four preparations stored at 4 °C, immediately after mixing (day 0), and on days 7, 14, 28, 42, 56, 70, and 91 days during storage. Rifampin wes measured by a stability-indicating HPLC method. RESULTS: The measured mean concentrations of rifampin were nearly 100 percent of the initial concentration in the suspension prepared from iv rifampin solution (method A) during the first 56 days of storage. In contrast, the measured concentrations were substantially lower than expected in the suspensions prepared by methods B, C, and D. The mean rifampin concentrations in suspensions prepared by methods B, C, and D were only 14.5, 38.6, and 68 percent, respectively, of the initial concentration achieved by method A. The rifampin concentrations increased with storage time in suspensions prepared by methods B, C, and D. The mean rifampin concentration was lower than 90 percent during the first 14 days with methods B and C, and the first 7 days with method D. The highest mean concentrations were observed on day 42 with method B, and on day 28 with methods C and D. All methods yielded 90% of the labeled potency (10 mg/mL) on day 56. CONCLUSIONS: Our results showed that preparation method can influence the dispersion, and thus the measured concentration, of rifampin in aliquots of suspensions prepared from capsules and stored in plastic bottles. Suspensions prepared from capsules led to lower-than-expected rifampin concentrations; those prepared from iv rifampin did not. Rifampin was stable in each type of suspension for 56 days at 4 °C.

Stability of Bortezomib 1-mg/mL Solution in Plastic Syringe and Glass Vial

2005 ◽  
Vol 39 (9) ◽  
pp. 1462-1466 ◽  
Author(s):  
Pascal André ◽  
Salvatore Cisternino ◽  
Fouad Chiadmi ◽  
Audrey Toledano ◽  
Joël Schlatter ◽  
...  
Keyword(s):  
Storage Temperature ◽  
Color Change ◽  
Hplc Method ◽  
Initial Concentration ◽  
Plastic Syringe ◽  
The Mean ◽  
The Stability ◽  
And Storage ◽  
Mean Concentration ◽  
Antineoplastic Chemotherapy

BACKGROUND: The proteasome inhibitor bortezomib (BTZ), used in antineoplastic chemotherapy, must be diluted in NaCl 0.9% for injection and stored for no more than 3 hours in a syringe or 8 hours in a vial. Better information on its stability could improve storage. OBJECTIVE: To assess the stability of BTZ solution (1 mg/mL) in syringes and vials. METHODS: BTZ 1-mg/mL solutions were prepared by adding sterile NaCl 0.9% to Velcade vials containing 3.5 mg of lyophilized BTZ. Syringes were filled with 1 mL of solution and stored in the dark at 5 °C or 60 °C; others were not protected from light and stored at 22 °C. Velcade vials containing 1 mL of solution were stored at 5 °C in the dark. Samples were taken at various times over 23 days and assayed in duplicate. An HPLC method for assaying the stability of BTZ was validated. Appearance and pH were recorded. RESULTS: There was no color change or precipitation in the samples, and the pH was stable. Oxidation, light, and storage temperature all affected the chemical stability of BTZ. The mean concentrations of BTZ in syringes stored for 2, 3, and 5 days at 60, 22, and 5 °C were >95% of the initial concentration. The mean concentration of BTZ in vials stored for 5 days at 5 °C was >95% of the initial concentration. CONCLUSIONS: BTZ stored refrigerated in vials or syringes and protected from light is chemically stable for 5 days after reconstitution.

Stability of Spironolactone in an Extemporaneously Prepared Suspension at Two Temperatures

1993 ◽  
Vol 27 (10) ◽  
pp. 1198-1199 ◽  
Author(s):  
Milap C. Nahata ◽  
Richard S. Morosco ◽  
Thomas F. Hippie
Keyword(s):  
Storage Period ◽  
Hplc Method ◽  
Initial Concentration ◽  
Ph Changes ◽  
Stability Indicating ◽  
Two Temperatures ◽  
The Mean ◽  
Glass Bottles ◽  
The Stability ◽  
Mean Concentration

OBJECTIVE: To determine the stability of spironolactone in an extemporaneously prepared suspension at 22 and 4°C over a three-month storage period. DESIGN: Spironolactone suspension (1 mg/mL) was prepared in syrup NF, carboxymethylcellulose, and purified water USP. The suspension was stored in ten amber glass prescription bottles; five were stored at 22°C and five at 4°C. Samples were drawn from each bottle and analyzed in duplicate (n=10) on days 0, 7, 14, 28, 42, 56, 70, and 91. Spironolactone concentrations were measured by a reproducible and stability-indicating HPLC method. Inspection of visual and pH changes also was performed on each study day. RESULTS: The mean concentration of spironolactone was always higher than 98 percent of its initial concentration. The pH and appearance of the suspension did not change substantially. CONCLUSIONS: Spironolactone was stable in a suspension containing syrup, carboxymethylcellulose, and purified water for three months during storage in amber glass bottles at both 22 and 4°C.

Comparison of Sample Preparation Methods for Recovering Salmonella from Raw Fruits, Vegetables, and Herbs

2001 ◽  
Vol 64 (10) ◽  
pp. 1459-1465 ◽  
Author(s):  
ANDREA B. BURNETT ◽  
LARRY R. BEUCHAT
Keyword(s):  
Sample Preparation ◽  
Pathogenic Bacteria ◽  
Preparation Method ◽  
Morphological Characteristics ◽  
Processing Method ◽  
Sample Processing ◽  
Processing Methods ◽  
Preparation Methods ◽  
Wide Range ◽  
The Mean

Methods for preparing raw fruits, vegetables, and herbs for enrichment or direct plating to determine the presence and populations of pathogenic bacteria vary greatly. A study was done to compare three sample processing methods (washing in 0.1% peptone, stomaching, and homogenizing) for their influence on recovery of Salmonella inoculated onto 26 types of raw produce. The mean numbers of Salmonella recovered from 10 fruits, 11 vegetables, and 5 herbs using all three processing methods were 7.17, 7.40, and 7.27 log10 CFU/sample, respectively. Considering all 26 types of produce and all processing methods, the number of Salmonella recovered ranged from 7.24 to 7.29 log10 CFU/sample, with no significant differences attributable to a particular sample processing method. Mean percent recoveries of Salmonella from washed, stomached, and homogenized produce were 39.4, 44.7, and 42.4%, respectively. Mean percent recoveries from fruits, vegetables, and herbs, regardless of sample preparation method, were 41.7, 50.1, and 25.9%, respectively. The number of Salmonella recovered from stomached and homogenized produce, but not washed produce, with pH ≤ 4.53 was significantly less than the number recovered from produce with pH from 5.53 to 5.99, suggesting that the acidic environment in stomachates and homogenates was lethal to a portion of Salmonella. Reduced percent recoveries from herbs (pH 5.94 to 6.34) is attributed, in part, to antimicrobials released from plant cells during sample preparation. Overall, the type of processing method did not substantially affect the number of Salmonella recovered from the 26 types of raw produce representing a wide range of structural and morphological characteristics, composition, and pH. The influence of sample size, diluent composition, and processing time on efficiency of recovery of Salmonella and other pathogens needs to be evaluated before a method(s) for processing samples of raw produce can be recommended.

Effect of the preparation method and storage time on the in vitro protein digestibility of maize tortillas

2018 ◽  
Vol 84 ◽  
pp. 7-12 ◽  
Author(s):  
A. Martínez-Velasco ◽  
J. Alvarez-Ramirez ◽  
E. Rodríguez-Huezo ◽  
M. Meraz-Rodríguez ◽  
E.J. Vernon-Carter ◽  
...  
Keyword(s):  
Storage Time ◽  
Preparation Method ◽  
Protein Digestibility ◽  
In Vitro Protein Digestibility ◽  
And Storage ◽  
Vitro Protein

scholarly journals STABILITY INDICATING RP-LC ASSAY METHOD FOR CARISOPRODOL

2017 ◽  
Vol 9 (6) ◽  
pp. 79
Author(s):  
M. Sangeetha ◽  
Tirumala . ◽  
Nagamallika .
Keyword(s):  
Degradation Products ◽  
Drug Product ◽  
Hplc Method ◽  
Assay Method ◽  
Pharmaceutical Dosage Forms ◽  
Stability Indicating ◽  
Photolytic Degradation ◽  
Ich Guidelines ◽  
The Mean

Objective: A reverse phase stability-indicating HPLC method was developed for the determination of Carisoprodol in pharmaceutical dosage forms. The chromatographic elution was achieved on C18, 250 mm × 4.6 mm, 5-μm particle size column.Methods: The mobile phase contains a mixture of water and acetonitrile in ratio of 60:40 v/v. The flow rate was 1.0 ml min-1 and was detected by Refractive index detector.Results: The method was proven to be linear over a range of 1 to 4 mg/ml with a mean correlation coefficient of 0.99998. The %mean recovery is in the range of 100.55% to 101.11% and %RSD was less than 1.0% between preparations. The % RSD for Assay results of initial sample preparation in different intervals of 0hr, 24 h, 30 h and 48 h was less than 1.0%. To establish stability-indicating capability of the method, drug product was subjected to the stress conditions of acid, base, oxidative, hydrolytic, thermal and photolytic degradation. The degradation products were well resolved from Carisoprodol.Conclusion: The developed method was validated as per international ICH guidelines with respect to specificity, linearity, accuracy, precision and robustness.

scholarly journals Isomers of c18:1 and c18:2 Acids in Fresh and Stored Fermented Milks Produced with Selected Starter Cultures

2016 ◽  
Vol 34 (No. 5) ◽  
pp. 391-396 ◽  
Author(s):  
Paszczyk Beata ◽  
Brandt Waldemar ◽  
Łuczyńska Joanna
Keyword(s):  
Storage Time ◽  
Octadecadienoic Acid ◽  
Starter Culture ◽  
Fermented Milk ◽  
Starter Cultures ◽  
Trans Isomers ◽  
The Mean ◽  
Fresh Products ◽  
And Storage

The effect of the applied starter cultures and storage time of fermented milk drinks on the content of cis-9, trans-11 octadecadienoic acid (CLA), as well as trans isomers of C18:1 and C18:2 acids were evaluated. The analysed fermented milk drinks were produced by the thermostat method and with three different starter cultures. Analyses were carried out for freshly produced fermented milk drinks and for stored drinks (analyses after 6, 13, and 21 days of storage). The study demonstrated that the type of applied starter culture and storage time affected the content of CLA and of trans isomers of C18:1 acid in fermented milk drinks. Among the starter cultures applied, only the Ceska-star Y508 culture caused a significant increase in CLA content in the stored fermented milk drinks. The mean content of CLA in fresh drinks reached to 3.60 mg/g fat. The significantly higher CLA contents (3.85 and 3.89 mg/g fat) were found in drinks after 6 and 13 days of storage, respectively. The content of trans isomers of C18:1 acid in fresh products was 15.92 mg/g fat. In drinks analysed after 6 days of storage it was 17.14 mg/g fat.

scholarly journals MODEL KINETIKA DEGRADASI CAPSAICIN CABAI MERAH GILING PADA BERBAGAI KONDISI SUHU PENYIMPANAN (Kinetic Model of Capsaicin Degradation on Red Chilli Paste at Various Storage Temperature)

2014 ◽  
Vol 34 (03) ◽  
pp. 330 ◽  
Author(s):  
Dharia Renate ◽  
Filli Pratama ◽  
Kiki Yuliati ◽  
Gatot Priyanto
Keyword(s):  
Activation Energy ◽  
Particle Size ◽  
Shelf Life ◽  
Storage Time ◽  
Arrhenius Equation ◽  
Storage Temperature ◽  
Hplc Method ◽  
Kinetic Reaction ◽  
C 30 ◽  
And Storage

The objective of this research was to asses relationship between temperature and storage time of capsaicin degradation of red chilli paste and to measure activation energy and shelf life using the Arrhenius model. The treatmens were storage temperature (20°C, 30°C, 40°C) and storage times (0, 2, 4, 6, 8, 10 weeks).  Parameters analyzed were capsaicin content using HPLC method, pH, and particle size.  The data was analyzed using linier regression and Arrhenius equation  The results showed that temperature condition and storage time affected capsaicin degradation of red chilli paste, unlike pH and particle size.  The longer storage time the lower capsaicin content.  The capsaicin content of red chilli paste storedat 30°C and 40°C in week-4 was 746,36 μg/g and 714,19 μg/g respectively, and it declined to 149,31 μg/g and 136,77 μg/g after being stored for ten weeks.  Research concluded that red chilli paste stored for 10 weeks at 20°C caused the lowest capsaicin degradation from   916.8029 μg/g  to 683.8097 μg/g. Degradation rate of capsaicin followed the first order reaction.  Arrhenius equation for capsaicin was  Y= -9356.3x + 27.836, (R=0.76), and activation energy was 18.581 kcal/mol.  Shelf life determination of capsaicin followed kinetic reaction equation of the fi rst order  i.e t = ln(Ao-At)/k.  The self life of red chilli paste stored at 20°C, 30°C and 40°C were 10.62 weeks, 8.62 weeks and 8.45 weeks respectively.Keywords: Red chilli paste, degradation, capsaicin, particle size, kinetic reaction ABSTRAKTujuan penelitian untuk mengkaji hubungan suhu dan lama penyimpanan terhadap degradasi capsaicin cabai merah giling serta menghitung energi aktivasi dan waktu simpan dengan pendekatan model persamaan Arrhenius. Perlakuan terdiri dari dua faktor yaitu suhu penyimpanan (20°C, 30°C, dan 40°C) serta lama penyimpanan (0, 2, 4, 6, 8 dan 10minggu). Metode analisis untuk kadar capsaicin menggunakan HPLC. Analisis pendukung yaitu pH dan ukuran partikel.  Data disajikan dengan grafi k persamaan regresi linier dan persamaan Arrhenius.  Hasil penelitian menunjukkan bahwa kondisi suhu dan lama penyimpanan berpengaruh terhadap degradasi capsaicin cabai merah giling, namun, pH dan ukuran partikel tidak berpengaruh secara signifi kan.  Semakin lama penyimpanan maka kandungan capsaicin semakin menurun.  Kadar capsaicin cabai giling yang disimpan pada suhu 30°C dan 40°C  pada minggu ke-empat masing masing sebesar 746,36 μg/g dan 714,19 μg/g menurun perlahan sampai pada  minggu ke-10 menjadi 149,31 μg/g dan 136,77 μg/g.  Dari hasil penelitian disimpulkan bahwa kadar capsaicin cabai giling yang disimpan pada suhu 20°C selama 10 minggu merupakan degradasi terendah dari 916,80 μg/g menjadi 683,81 μg/g.  Laju degradasi capsaicin mengikuti orde satu.  Persamaan Arrhenius untuk Capsaicin adalah Y= 27,836-9356,3x (R=0,76) dan energi aktivasisebesar 18581,65 kal/mol. Penentuan umur simpan capsaicin mengikuti persamaan kinetika reaksi orde satu yaitu t =ln(Ao-At)/k, maka umur simpan capsaicin cabai merah giling yang disimpan pada suhu 20°C, 30°C dan 40°C berturutturut sebesar 10,64 minggu; 8,62 minggu dan 8,45 minggu.Kata kunci: Cabai merah giling, degradasi, capsaicin, ukuran partikel, kinetika reaksi

scholarly journals Pengaruh Konsentrasi Natrium Asetat dan Lama Penyimpanan terhadap Mutu Mi Basah

2017 ◽  
Vol 2 (4) ◽  
pp. 454-463
Author(s):  
Muhammad Hendra ◽  
Nida El Husna ◽  
Melly Novita
Keyword(s):  
Protein Content ◽  
Sodium Acetate ◽  
Storage Time ◽  
Ash Content ◽  
Acetate Concentration ◽  
Average Value ◽  
The Mean ◽  
Four Levels ◽  
And Storage

Abstrak. Penelitian ini bertujuan untuk mengetahui pengaruh konsentrasi natrium asetat dan lama penyimpanan terhadap mutu mi basah matang. Selain itu penelitian ini juga bertujuan untuk menentukan konsentrasi natrium asetat yang sesuai untuk digunakan sebagai bahan pengawet mi basah matang. Penelitian ini menggunakan Rancangan Acak Lengkap (RAL) faktorial yang terdiri atas dua faktor. Faktor pertama adalah konsentrasi natrium asetat (N) yang terdiri atas empat taraf yaitu N1 = 0%, N2=  0,3%, N3 = 0,6%, N4 = 0,9% . Faktor kedua adalah lama penyimpanan (P) terdiri atas empat taraf yaitu P1= 0 hari, P2= 1 hari, P3= 2 hari, P4= 3 hari. Kombinasi penelitian dalam penelitian ini adalah 4 x 4 = 16 kombinasi perlakuan dengan menggunakan tiga (3) kali ulangan, sehingga diperoleh 48 satuan percobaan. Berdasarkan hasil penelitian, diperoleh nilai rata-rata hasil analisis mi basah yaitu: kadar air 64,33%, total mikroba 7,11 cfu/ml, pH (derajat keasaman) 7,06. Uji organoleptik diperoleh nilai rata-rata pada warna 3,01 (putih kekuningan), aroma 3,80 ( tercium aroma khas mi,tapi agak asam) tekstur 3,62 (agak tidak lunak) dan penampakan 3,46 (agak berlendir). Analisis kadar abu dan kadar protein dilakukan dari hasil perlakuan terbaik berdasarkan uji organoleptik, nilai terbaik diperoleh pada penambahan konsentrasi natrium asetat 0,9 % dimana mampu mempertahankan organoleptik tekstur dan penampakan mi basah matang selama 2 hari pada suhu ruang. Hasil analisis rata-rata kadar abu mi basah adalah 1,93% dan rata-rata kadar protein 12,26 %The effects of sodium acetat consentration and storage time on quality of wet noodlesAbstract. This research is aimed to determine the effect of sodium acetate concentration and storage time on the quality of wet noodles. In addition, this research also aims to determine the appropriate concentration of sodium acetate to be used as a preservative of wet noodles. This research uses Factorial Random Design (RAL) which consists of two factors. The first factor is the concentration of sodium acetate (N) consisting of four levels, namely N1 = 0%, N2 = 0.3%, N3 = 0.6%, N4 = 0.9%. The second factor is the length of storage (P) consists of four levels ie P1 = 0 days, P2 = 1 day, P3 = 2 days, P4 = 3 days. The combination of the research in this study was 4 x 4 = 16 treatment combinations using three (3) replications, so that 48 experimental units were obtained. Based on the research, obtained the average value of wet noodles analysis results are: water content 64.33%, total microbe 7.11 cfu / ml, pH (acidity degree) 7.06. The organoleptic test obtained an average value of 3.01 (yellowish white), 3.80 (smelled of typical aroma, but slightly acidic) texture 3.62 (mildly not tender) and 3.46 appearance (slightly slimy). Analysis of ash content and protein content was performed from the best treatment based on organoleptic test where the best value was obtained in addition of 0.9% sodium acetate concentration. The mean analysis of wet noodle ash content was 1.93% and the mean protein content of 12.26%

scholarly journals A Validated Stability Indicating RP-HPLC Method for Quantification of Cilnidipine in Bulk and in Tablet Dosage Form

2021 ◽  
Vol 37 (5) ◽  
pp. 1167-1177
Author(s):  
Rameshwar Gholve ◽  
Sanjay Pekamwar
Keyword(s):  
Detection Limit ◽  
Dosage Form ◽  
Hplc Method ◽  
Drug Substance ◽  
Solution Stability ◽  
Stability Indicating ◽  
Quantitation Limit ◽  
Rp Hplc ◽  
The Mean ◽  
Tablet Dosage

A stability indicating RP-HPLC method has been developed for quantification of Cilnidipine in bulk and in tablet dosage form. The chromatographic analysis was accomplished at ambient temperature on Xttera RP18 (100 x 4.6 mm, 3.5 µm) column and 1 mL/min flow rate by using Eluent composed of 10 mM phosphate buffer pH 2.6 with Acetonitrile (300:700, v/v). The UV detection at the wavelength of 240 nm was carried out using 20 µL injection volume. The Cilnidipine retention time was found to be 3.029 min. The method in the range of 40.0573 – 120.1719 µg/mL was found to be linear (R2 = 0.999) with a detection limit and quantitation limit of 1.2038 and 3.6478 μg/mL, respectively. The mean recovery % over the three tested levels of 50, 100, and 150% were found to be 98.74, 99.60, and 98.23%, respectively. The mean % assay of 99.29 for method repeatability and 98.82 for intermediate precision were found with % RSD of 0.68 and 0.31, respectively. Cilnidipine drug substance and their product exposed to acid, alkali, oxidative, thermal, photolytic, and humidity stress conditions. The acid, alkali, and photolytic induced stress studies signifying the formation of a variety of degradants and their peaks were well resolved from that of active analyte peak. Hence, it is recommended that the Cilnidipine drug substance, as well as drug product, should be store in a tightly closed container protected from light. The method as per ICH guidelines was validated for specificity, linearity, detection limit, quantitation limit, precision, accuracy, robustness, solution stability, and can be effectively used for routine analysis.

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