Evaluation of non-isothermal methods in stability studies of human insulin pharmaceutical preparations

2009 ◽  
Vol 49 (4) ◽  
pp. 916-922 ◽  
Author(s):  
Alexis Oliva ◽  
Marta Suárez ◽  
Juan Ramón Hernández ◽  
Matías Llabrés ◽  
José B. Fariña
Keyword(s):  
Human Insulin ◽  
Pharmaceutical Preparations ◽  
Stability Studies

scholarly journals Spectrofluorometric Determination of Verapamil Hydrochloride in Pharmaceutical Preparations and Human Plasma Using Organized Media: Application to Stability Studies

2006 ◽  
Vol 89 (6) ◽  
pp. 1565-1572 ◽  
Author(s):  
Mohamed Walash ◽  
Fathalla Belal ◽  
Nahed El-Enany ◽  
Amina Abdelsalam
Keyword(s):  
Human Plasma ◽  
Biological Fluids ◽  
Sodium Dodecyl ◽  
Pharmaceutical Preparations ◽  
Pharmaceutical Formulations ◽  
Official Method ◽  
Stability Studies ◽  
Verapamil Hydrochloride ◽  
Spiked Human Plasma

Abstract A highly sensitive spectrofluorometric method was developed for the determination of verapamil hydrochloride (VP HCl) in pharmaceutical formulations and biological fluids. The proposed method is based on investigation of the fluorescence spectral behavior of VP HCl in micellar systems, such as sodium dodecyl sulfate (SDS) and β-cyclodextrin (β-CD). In aqueous solutions of borate buffer of pH 9 and 8.5, VP HCl was well incorporated into SDS and β-CD, respectively, with enhancement of its native fluorescence. The fluorescence was measured at 318 nm after excitation at 231 nm. The fluorescence intensity enhancements were 183 and 107% in SDS and in β-CD, respectively. The fluorescence-concentration plots were rectilinear over the range of 0.020.2 and 0.020.25 μg/mL, with lower detection limits of 5.58 × 103 and 3.62 × 103 μg/mL in SDS and β-CD, respectively. The method was successfully applied to the analysis of commercial tablets and the results were in good agreement with those obtained with the official method. The method was further applied to the determination of VP HCl in real and spiked human plasma. The mean % recoveries in the case of spiked human plasma (n 4) was 92.59 3.11 and 88.35 2.55 using SDS and β-CD, respectively, while that in real human plasma (n 3) was 90.17 6.93 and 89.17 6.50 using SDS and β-CD, respectively. The application of the method was extended to the stability studies of VP HCl after exposureto ultraviolet radiation and upon oxidation with hydrogen peroxide.

scholarly journals Polymorphic Forms of Lamivudine: Characterization, Estimation of Transition Temperature, and Stability Studies by Thermodynamic and Spectroscopic Studies

2012 ◽  
Vol 2012 ◽  
pp. 1-8 ◽  
Author(s):  
Renu Chadha ◽  
Poonam Arora ◽  
Swati Bhandari
Keyword(s):  
Transition Temperature ◽  
Enthalpy Of Solution ◽  
Pharmaceutical Preparations ◽  
Spectroscopic Studies ◽  
Stability Studies ◽  
Order Form ◽  
Phase Pure ◽  
Melting Endotherm ◽  
Polymorphic Forms ◽  
Stable Forms

The present study is focused on estimation of transition temperature and stability of various forms of lamivudine. The forms were recrystallized from variety of solvents and preliminarily identification on the basis of SEM revealed existence of three forms (Forms I, II, III). DSC scans of Forms I and III show that these are metastable and undergo heat mediated transformation to Form IH and Form IIIH, respectively. Form II is phase pure with single sharp melting endotherm at 178.6°C. The thermal events are visually observed by hot stage microscopy. Enthalpy of solution of the forms is endothermic and magnitude varies in the order Form II > Form IL > Form IIIL suggesting Form IIIL to be least crystalline which is well correlated with XRPD data. The transition temperature of the polymorphic pairs IL/IH and IIIL/IIIH derived from enthalpy of solution and solubility data revealed monotropy whereas enantiotropy exists in IIIH/II. The slurry experiments showed Form II to be thermodynamically most stable. Forms IL and IIIL though stable in water are converted to Form II in ethanol, acetonitrile, and propanol after 1 day. Form IIIL is converted to Form IL in water after 7 days and the observation is of importance as this instability can effect the pharmaceutical preparations whereas Form IL shows a balance between stability and solubility.

A fast spectrofluorimetric method for determination of carbinoxamine maleate in the nano-molar range. Application to pharmaceutical preparations, biological fluids and stability studies

2018 ◽  
Vol 10 (31) ◽  
pp. 3851-3858 ◽  
Author(s):  
Fatma Ahmed Aly ◽  
Nahed EL-Enany ◽  
Heba Elmansi ◽  
Amany Nabil
Keyword(s):  
Human Plasma ◽  
Biological Fluids ◽  
Pharmaceutical Preparations ◽  
Pure Form ◽  
Stability Studies ◽  
Spiked Human Plasma ◽  
Spectrofluorimetric Method

Carbinoxamine maleate (CBX), which is a common ingredient of cold and cough treatment preparations, is determined by a sensitive, simple and convenient spectrofluorimetric method in its pure form, pharmaceutical preparations and spiked human plasma.

Beyond-Use Dates Assignment for Pharmaceutical Preparations: Example of Low-Dose Amiodarone Capsules

2021 ◽  
pp. 875512252110155
Author(s):  
Damien Brun ◽  
Christophe Curti ◽  
Edouard Lamy ◽  
Christophe Jean ◽  
Pierre Bertault-Peres ◽  
...  
Keyword(s):  
Microcrystalline Cellulose ◽  
Low Dose ◽  
Pharmaceutical Preparations ◽  
The United States ◽  
Stability Study ◽  
Potential Drug ◽  
Stability Studies ◽  
United States Pharmacopoeia ◽  
Amiodarone Hydrochloride

Background: Beyond-use dates (BUDs) in compounding practice are assigned from stability studies. The United States Pharmacopoeia (USP 42 NF 37) suggested to assign a 6 months BUD for dry oral forms. A new pediatric formula of amiodarone capsules was implemented in our hospital, with 3 dosages (5 mg, 20 mg, and 50 mg). Objective: BUD of these new formulas had to be determined by stability study. Methods: The method for the determination of amiodarone content was validated to be stability indicating, and a stability study was performed. Different excipients commonly used for capsule compounding were compared. Results: We found that, with microcrystalline cellulose as excipient, 50 mg amiodarone capsules were stable for 1 year, whereas 5 mg and 20 mg capsules were not. This difference was studied, and lactose or mannitol were found to be better excipients for 5 mg amiodarone capsules, despite their potential side effects. A potential drug-excipient interaction between microcrystalline cellulose and amiodarone hydrochloride is described. Conclusion: Amiodarone hydrochloride/microcrystalline cellulose capsules have a BUD of 1 month for 5 mg capsules, 6 months for 20 mg, and 1 year for 50 mg.

scholarly journals Spectrofluorometric Determination of Olanzapine and Fluphenazine Hydrochloride in Pharmaceutical Preparations and Human Plasma Using Eosin: Application to Stability Studies

2008 ◽  
Vol 91 (6) ◽  
pp. 1309-1317 ◽  
Author(s):  
Fathalla Belal ◽  
Amina El-Brashy ◽  
Nahed El-Enany ◽  
Nihal El-Bahay
Keyword(s):  
Human Plasma ◽  
Reaction Pathway ◽  
Pharmaceutical Preparations ◽  
Stability Studies ◽  
Quenching Effect ◽  
Spectrofluorometric Determination ◽  
The Mean ◽  
Kinetics Of ◽  
Good Agreement

Abstract A simple, rapid, and sensitive spectrofluorometric method has been developed for the determination of olanzapine (OLZ) and fluphenazine hydrochloride (FPZ HCl). The proposed method is based on the quantitative quenching effect of the studied drugs on the native fluorescence of eosin at pH 3.4 and 3.2 for OLZ and FPZ HCl, respectively. The fluorescence was measured at 547 nm after excitation at 323 nm. The fluorescence-concentration plots were rectilinear over the range of 0.051.0 and 0.101.0 g/mL, with lower detection limits of 1.8 103 and 1.2 103 g/mL, for OLZ and FPZ HCl, respectively. The proposed method was successfully applied to the analysis of commercial tablets and ampules containing the drugs, and the results were in good agreement with those obtained with reference methods. The proposed method was further applied to the determination of OLZ in spiked human plasma. The mean recovery was 98.62 0.24 (n 4). The method was also used for stability studies of FPZ HCl upon oxidation with hydrogen peroxide, and the kinetics of the reaction were studied. A proposal for the reaction pathway was postulated.

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