Development and Validation of Bio Analytical Method for Estimation of Bortezomib in k3 EDTA Human Plasma Using HPLC-ESI-MS/MS and Its Application to a Bioequivalence & CME Studies
Journal Title: Journal of Pharmaceutical Research International - Year 2016, Vol 14, Issue 4
Abstract
Purpose: To develop a highly selective, reproducible & precise rugged bio analytical method for estimation of Bortezomib (BTZ), “A Protease Inhibitor” in human plasma by validating the developed method in accordance to US-FDA guidelines. Methodology Envisaged: BTZ D3 was used as an internal standard (ISTD) for the determination of BTZ in human plasma using a rapid & specific liquid chromatographic – Electron Spray Ionization –Mass spectrometric method. The analytical method was moduled with liquid-liquid phase extraction by using annular centrifugal contactor & the samples were analyzed by HPLC, on a column - ACE 5CN (150 x 4.6 mm 5 µm), using mobile phase consisting of ammonium formate buffer: ACN (25:75 v/v), delivered at 1.0 ml/min & 90% flow spitting. Applied Bio system MDS Sciex API 3000 Triple Quadruple MS equipped with Turbo Ion Spray (TIS) as LC/MS interface was used in for MS detection. TIS with multiple reaction monitoring (MRM) were acquired by ESI mass spectra, using the transitions m/z 362.95→310.21 & m/z 172.64→146.06 to quantify BTZ & BTZ D3 respectively. Results: % variability was ≤ 5.52 & ≤ 6.15 [that was ≤ 15], indicating the specificity of the method, showing no matrix interferences across the elution system. Acceptance is ranging between -8.30 to 2.83 & -4.32 to 1.00% (< 5% CV) & accuracy in the range of 92.73 – 102.20 (< 10% difference) was observed over a linear range of 2.00 – 1000 ng/mL. The mean (n=3) correlation coefficient was 0.9991 & overall mean recovery was 85.62%. Retention time for drug & ISTD is found out to be 0.08 & 0.07; % CV of area ratio is 1.91% & area ratio ≤ 2.51%, which indicated system suitability. Interpretation and Conclusion: The intended analyte is stable below 10ºC in all the performed stability experimentation & within the acceptance limits. It can be used for investigating drug concentration in routine quality control analysis in API & its pharmaceutical dosage forms.
Authors and Affiliations
Ravi Pratap Pulla, K. Vanitha Prakash, U. B. Abhini, B. Naga Maheswari, V. Divya, M. V. Shushmitha
Keywords
Related Articles
- EP ID EP342251
- DOI 10.9734/BJPR/2016/30565
- Views 127
- Downloads 0
Fungal Metabolites and Leishmaniasis: A Review
Among the most neglected tropical diseases in the world, one is leishmaniasis, which is caused by parasites that belongs to protozoans of the genus Leishmania. Leishmaniasis can be controlled profoundly by using chemothe...
Anti-inflammatory Effects of Quranic Plants’ Mixture: A New Pharmaceutical Product
Aims: This work was carried out to determine anti-inflammatory effects of this new pharmaceutical product (Quranic Plants’ Mixture) and also to study side effects of this product on many important organs of the body of i...
A Study of Prophylactic Effect Against Diabetes of Two Ayurvedic Drugs ‘Jambadyarista’ and ‘Bohumutrantak Ras’ in Normal as well as Alloxan-induced Diabetic Rats
Aims: The present study was designed to evaluate the anti-diabetic as well as prophylactic activity of Jambadyarista and Bohumutrantak Ras in alloxan-induced diabetic rats. Study Design: Study the prophylactic and antig...
Anti-proliferative Effect of Isoflavones Isolated from Soybean and Soymilk Powder on Lymphoma (DG 75) and Leukemia (CEM) Cell Lines
Aim: Isoflavones in soybean have been linked to reduced risk of some cardiovascular diseases as well as some type of cancers. Extensive epidemiological, in-vitro and animal data suggests lower incidence of cardiovascular...
Attitudes, Practice and Predictors of Rational Use of Medicines among Medicines Prescribers and Dispensers in Nnewi Nigeria
Aims: Rational use of medicines (RUM) requires that patients receive the appropriate medicine, in the proper dose, for an adequate period of time, and at the lowest cost to them and their community. Positive attitude and...