Dibin, E (2012) A Validated Stability-Indicating Hplc Method for Acetazolamide Sr Capsule in the Presence of Degradation Products and its Process Related Impurity. Masters thesis, R V S College of Pharmaceutical Sciences, Coimbatore.
|
Text
2605079dibine.pdf Download (4MB) | Preview |
Abstract
The current study was to develop a validated, specific and stability indicating reverse phase liquid chromatographic method for the quantitative determination of Acetazolamide and its related substances. This study is designed to develop a novel method for the estimation of Acetazolamide SR capsules and its related substance like impurity –D (process related degradation impurity) and impurity–E (Forced Degradation impurity). To develop a novel stability indicating method for the estimation of Acetazolamide and its related substance, To validate the developed method for the estimation of selected drug and its related substances in sustained release formulation as per ICH guidelines. A simple, economic, selective, precise and stability-indicating HPLC method has been developed and validated for analysis of Acetazolamide SR Capsules and its related substances. Reversed phase chromatography was performed on a C-18 column with Acetonitrile : Buffer as mobile phase at a flow rate of 1.0mL/min. Detection was performed at 265nm and a sharp peak was obtained for Acetazolamide at a retention time of 7.5 min. The %RSD for the peak area of LOQ level is not more than 2. The method was validated for accuracy, precision, reproducibility, specificity and robustness, in accordance with ICH guidelines. Statistical analysis proved the method was precise, reproducible, selective, specific, and accurate for the analysis of Acetazolamide SR capsules. The wide linearity range, sensitivity, accuracy, short retention time and simple mobile phase imply the method is suitable for routine quantification of Acetazolamide with high precision and accuracy. The proposed method can be used as alternative method to the reported ones for the routine determination of selected drugs under the study in bulk and pharmaceutical dosage forms. In RS method all the peaks were well separated, peak purity was passing for the peaks and finally method was a stability-indicating method. Thus the purpose of the present investigation was successfully achieved. Pharmaceutical analysis simply means analysis of pharmaceuticals. Today pharmaceutical analysis entails much more than the analysis of active pharmaceutical ingredients or the formulated product. The pharmaceutical analyst plays in a major rule in assuring identity, safety, efficacy, purity, and quality of a drug product. New methods are now being developed with a great deal of consideration to worldwide harmonization. As a result, new products can be assured to have comparable quality and can be brought to international markets faster.
| Item Type: | Thesis (Masters) |
|---|---|
| Uncontrolled Keywords: | chromatographic; Acetazolamid; ICH guidelines |
| Subjects: | PHARMACY > Pharmaceutical Analysis |
| Depositing User: | Ravindran C |
| Date Deposited: | 09 Aug 2017 07:40 |
| Last Modified: | 09 Aug 2017 07:40 |
| URI: | http://repository-tnmgrmu.ac.in/id/eprint/2604 |
Actions (login required)
 |
View Item |
