A simple and sensitive size exclusion HPLC method was developed and validated for the analysis of lenograstim (rHuG-CSF) in pharmaceutical formulations. Analyses were performed on a Waters HPLC ...system employing a Fractogel® EMD BioSEC column and isocratic elution with phosphoric acid (pH 2.5; 0.1 M) containing 150 mmol L
−1
NaCl at a flow rate of 2.0 mL min
−1
. The validation results demonstrate that the proposed method is suitable for determination of lenogratsim in pharmaceutical formulations. Furthermore, the proposed SEC-HPLC method was able to separate and detect the aggregates and the intact protein.
Diazepam (DZP) has become a commonly used drug for treatment of acute repetitive epileptic seizures and febrile convulsions in children. Considering the advantages of rectal administration of DZP, ...the objective of our study was to formulate and evaluate rectal hydrogels containing DZP as a drug substance in combination with suitable co-solvents and preservatives. Prepared HPMC (hydroxypropyl methylcellulose) hydrogels containing different concentrations of DZP (2, 4 and 6 mg mL(-1)) manifested good quality in respect to physico-chemical parameters (pH value, drug content, ingredients content and viscosity), antimicrobial efficiency and microbiological quality. Under the proposed HPLC conditions, satisfactory separation of DZP and the preservatives used was achieved. In vitro release studies have shown that the total amount of DZP was released in a period of 3 h. Prepared formulations were stable for four months at 26 degrees C (ambient temperature characteristic of the 2nd climate zone).
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