Vignesh, S (2018) RP-HPLC Method Development and Validation for related Substance of Cefixime Oral Suspension. Masters thesis, J.K.K.Nattraja College of Pharmacy, Komarapalayam.
|
Text
260564918vignesh.pdf Download (2MB) | Preview |
Abstract
Cefixime binds to specific penicelline binding protein (PBPs) located iniside the bacterial cell wall causing the inhibition of the third and last stage of bacterial cell wall synthesis, whiche final transpeptiation step of the peptidoglycan synthesis in the bacterial cell wall. Thus inhibiting biosynthesis and arresting cell wall assembly resulting in bacterial cell death. Cefixime is an orally active cephalosporin antibiotic which has in-vitro bactericidal against a wide variety of Gram-positive and Gram-negative organisms including Streptococcus pneumonia, Streptococcus pyrogens, Escherichia coli, Proteus mirabilis, Klebsiella species, Haemophilus influenzae, (beta-lactamase positive and negative), Moraxella (Branhamella) catarrhalis (betalactamase positive and negative). Cefixime is stable in the presence of beta-lactamase enzymes. Most strains of enterococci (Streptococcus faecalis, group D Streptococcus) and staphylococci (including coagulase positive and negative strains andmethicillin resistant strains) are resistant to cefixime. In addition, most strains of Enterobacter and Pseudomonas, bacteroides fragilis, Listeria monocytogenes and Clostridia are resistant to cefixime. AIM AND OBJECTIVES: The drug analysis plays an important role in the development of drugs, their manufacture and the therapeutic use. Pharmaceutical industries rely upon quantitative chemical analysis to ensure that the raw materials used and the final product obtained meets the required specification. The number of drugs and drug formulations introduced in to the market has been increasing. These drugs or formulation may be either in the new entities in the market or partial structural modification of the existing drugs The single component dosage form proves to be effective due to the mode of action on the body. The dosage forms including the presence of drug entities possess considerable challenge to the analytical chemist during the development of related substance procedure. For the present study of Cefixime was selected. The extensive literature survey carried out and revealed that there is one method reported for the Related substance of cefixime oral suspension. Hence an attempt was made to develop a specific, precise, accurate, linear, simple, rapid, validated and cost effective RPHPLC method for the study of these drugs in the dosage forms. CONCLUSION: From the reported literature, there were few methods established for the determination of Cefixime was concluded that method reported for the Related substance of Cefixime oral suspension the above selected single component dosage form, which promote to pursue the present work. The scope and object of the present work is to develop and validate a new simple HPLC method for related substance of Cefixime Oral suspension dosage form. In RP-HPLC method development, The Related substance of Cefixime oral suspension was carried out by using the Novapak C 18 column (3.9 X 150 mm) with 4-micron particle size. Injection volume of 10μl is injected and eluted with the mobile phase phosphate Buffer, Acetonitrile with the gradient programme pH 6.5, which is pumped at the flow rate of 1.0 ml/min. Detection was carried out at 254 nm. Quantitation was done by calibration curve method with the above mentioned optimized chromatographic condition. This system produced symmetric peak shape, good resolution and reasonable retention times of cefixime E isomer and cefixime were found to be resolution is 3.0 and retension time is 30.8 and 33.02 minutes respectively. The 0.4 μg/ml to 40 μg/ml of cefixime respectively. The slope intercept and correlation coefficient(s) were found to be, within the limit for which indicates excellent correlation factor Vs concentration of standard solutions. Precision of the developed methods was studied under system precision, method precision. The %RSD values for precision was found to be within the acceptable limit, which revealed that the developed method was precise. The developed method was found to be robust. The %RSD values for recovery percentage of Cefixime was found to be within the acceptable criteria. The result indicates satisfactory accuracy of method for estimation of the above mentioned drugs. Hence, the chromatographic method developed for Cefixime are rapid, simple, specific, sensitive, precise, Accurate. The RP-HPLC was simple and does not suffer from common excipients in pharmaceutical preparation and highly useful in the analysis of drugs in pharmaceutical formulation.
| Item Type: | Thesis (Masters) |
|---|---|
| Additional Information: | Reg.No: 261630210 |
| Uncontrolled Keywords: | RP-HPLC Method Development ; Validation ; Substance ; Cefixime Oral Suspension. |
| Subjects: | PHARMACY > Pharmaceutical Analysis |
| Depositing User: | Subramani R |
| Date Deposited: | 30 Jun 2019 12:52 |
| Last Modified: | 30 Jun 2019 12:52 |
| URI: | http://repository-tnmgrmu.ac.in/id/eprint/10669 |
Actions (login required)
 |
View Item |
