1.1 How define a SIM? According to FDA guideline (Guidance for Industry, Analytical Procedures and Methods Validation, FDA, 2000), a Stability Indicating Method (SIM) is defined as a validated analytical procedure that accurate and precisely measure active ingredients (drug substance or drug product) free from process impurities, excipients and degradation products. The FDA recommends that all ...

fluvoxamine maleate is a selective serotonin reuptake inhibitor, which is used for the treatment of different types of depressive disorders. in the present study, a stability indicating hplc method was developed and validated for the determination of fluvoxamine maleate. the chromatographic separation was carried out using a nova-pak cn column and a mixture of k2hpo4 50 mm (ph 7.0) and acetonit...

this paper describes two rapid, sensitive and specific methods for the determination of fulvestrant in pharmaceutical preparations by high performance liquid chromatography (hplc) and linear sweep voltammetry (lsv). hplc method was used to study the degradation behaviour. fulvestrant was subjected to degradation under the conditions of hydrolysis (acid and alkali), oxidation (30% h2o2). the lin...

a simple and reliable stability-indicating rp-hplc method was developed and validated for analysis of adefovir dipivoxil (adv).the chromatographic separation was performed on a c18 column using a mixture of acetonitrile-citrate buffer (10 mm at ph 5.2) 36:64 (%v/v) as mobile phase, at a flow rate of 1.5 ml/min. detection was carried out at 260 nm and a sharp peak was obtained for adv at a reten...

the objective of the study was to develop a simple, specific and stability-indicating hplc method for the simultaneous determination of creatine phosphate sodium (cps) and its related substances in pharmaceutical formulation. separation of creatine phosphate sodium from its major process impurities and degradation products was achieved on a hypersil bds c18 column (250 × 4.6 mm, 5 μm) with an a...

A simple and rapid stability indicating method based on capillary zone electrophoresis has been developed and validated for the analysis of buserelin (BUS). The best separations were achieved by using a bare fused silica capillary (75 m i.d.; 65.5 cm total, 57.0 cm effective length), phosphate buffer (pH = 3.00; 26.4 mM), at 35 °C. The sample was hydrodynamically injected at 50 mbar for 5 seco...

High performance liquid chromatography (HPLC) is an integral analytical tool in assessing drug product stability. HPLC methods should be able to separate, detect, and quantify the various drug-related degradants that can form on storage or manufacturing, plus detect and quantify any drug-related impurities that may be introduced during synthesis. Forced degradation studies of new chemical entit...

A simple and rapid stability indicating method based on capillary zone electrophoresis has been developed and validated for the analysis of buserelin (BUS). The best separations were achieved by using a bare fused silica capillary (75 m i.d.; 65.5 cm total, 57.0 cm effective length), phosphate buffer (pH = 3.00; 26.4 mM), at 35 °C. The sample was hydrodynamically injected at 50 mbar for 5 seco...