Stability of Temozolomide in Solutions Aimed for Oral Treatment Prepared From a Commercially Available Powder for Infusion.

Stability of temozolomide in solutions aimed for oral treatment prepared from a commercially available powder for infusion.

Pharm Methods. 2012 Jan; 3(1): 1-3
Nygren H, Eksborg S

Temozolomide (TMZ) is an alkylating agent with a broad spectrum of antitumor activity, including brain tumors in children. The oral use of TMZ is hampered by the lack of a suitable galenic formulation, since the capsules of TMZ (Temodal™) are large and difficult to swallow. A powder for preparation of a TMZ solution for intravenous administration (2.5 mg/mL) has recently been approved. A possibility to use this formulation for oral administration would facilitate TMZ administration.The aim of the present study was to investigate the stability of TMZ in solutions prepared from the commercially available powder for intravenous infusion.Solutions were prepared from the intravenous formulation by dissolving the powder in water. The degradation of TMZ was studied photometrically at 330 nm in two solutions, 2.5 mg/mL at room temperature (RT; 22°C) and 1.25 mg/mL at 5°C, prepared from the intravenous formulation.More than 90% of TMZ remained intact after storage for 9 days at RT (2.5 mg/mL) and 13 weeks at 5°C (1.25 mg/mL).The high stability of a TMZ solution prepared from the powder for infusion formulation makes it suitable for oral administration. Oral use of a TMZ solution facilitates administration of the drug to patients with difficulties to swallow capsules, and enables a more flexible and precise dosing. HubMed – drug


Application of UV spectrophotometric method for easy and rapid estimation of lafutidine in bulk and pharmaceutical formulation.

Pharm Methods. 2011 Oct; 2(4): 264-7
Jadhav K, Dhamecha D, Tate A, Tambe H, Patil MB

The present research work discusses the development of a UV estimation method for lafutidine. Simple, accurate, cost efficient, and reproducible spectrophotometric method has been developed for the estimation of Lafutidine in bulk and pharmaceutical dosage form.The Stock solution was prepared in a mixture of water and methanol (1:1). Further dilutions were made in water.The drug was determined at maximum wavelength (?max) 279 nm. Beers law was obeyed in the concentration range of 10-50 ?g/ml having line equation y = 0.0100x + 0.035 with correlation coefficient of 0.999. Results of the analysis were validated statistically and by recovery study.The result of analysis was validated as per ICH guidelines and this method can be used for the routine analysis of lafutidine formulation. HubMed – drug


Stress degradation studies on Telmisartan and development of a validated method by UV spectrophotometry in bulk and pharmaceutical dosage forms.

Pharm Methods. 2011 Oct; 2(4): 253-9
Patel K, Dhudasia K, Patel A, Dave J, Patel C

To develop and validate a simple, precise, accurate, and stability indicating a UV-method for estimation of Telmisartan (TELM). UV, HPLC, HPTLC, and many more experiments were carried out by taking single drug and also by combining with other drugs. However, Such type of studies was not reported.In both methods, TELM has the absorbance maxima at 296 nm. Method A involves method development and validation and Method B involves forced degradation study. In these methods, methanol was used as a solvent. Linearity was observed in the concentration range of 4-16 ?g/ml. Validation experiments were performed to demonstrate system suitability, specificity, precision, linearity, accuracy, robustness, LOD, and LOQ as per International Conference on Harmonization guidelines. Furthermore stability studies of TELM were carried out under acidic, alkali, neutral, oxidation, photolytic, and thermal degradation as per stability indicating assay methods.The results of analysis have been validated, and recovery studies were carried out using a standard addition method by adding specific drug amount (80%, 100%, and 120%) and show recovery studies in the range (99.26-101.26)%.The proposed method can be successfully applied for method development, validation, and stability study of TELM. HubMed – drug


Determination of theophylline in rabbit plasma by triple quadrupole LC/MS.

Pharm Methods. 2011 Oct; 2(4): 211-7
Babu AR, Thippeswamy B, Vinod AB, Ramakishore EG, Anand S, Senthil D

A simple, sensitive and rapid method was developed for quantitation of theophylline in rabbit plasma utilizing Triple Quadrupole LC/MS.An aliquot of 0.1 mL of plasma sample was extracted with ethyl acetate using Heidolph Vortex. The chromatographic separation was performed by using HyPURITY ADVANCE™ C18 Column (3 × 50 mm) with a mobile phase of 80% methanol and 20% 2 mM ammonium acetate buffer followed by MS/MS detection. The analyte was quantitated in positive ionization mode. Multiple reaction monitoring (MRM) using the transition m/z 181.1?124.2 and m/z 180.2?110.1 was performed to quantify theophylline with internal standard (IS, Phenacetin), respectively. The method had a total chromatographic runtime of 3 min and linear calibration curves over the concentration range of 50.418-5062.063 ng/mL. The lower limit of quantification (LLOQ) was 50.418 ng/mL Sodium heparin (3.50%) used as an anticoagulant to prepare rabbit plasma and samples were maintained at 10°C in the auto sampler during the assay period. Inter and intraday batch precision and accuracy of the method were determined by using six quality control samples.Average accuracies for the assay were 89 to 106%, inter and intra-day coefficients variation (CV) of <9% and the recovery is 39.30% for theophylline and 57.00% for Phenacetin.Currently we are extensively using this method in our laboratory for quantitative analysis of theophylline in rabbit plasma samples and proved to be simple, accurate and precise. HubMed – drug