Development, Evaluation and Rp-HPLC Method for Simultaneous Estimation of Quercetin, Ellagic Acid and Kaempferol in a Polyherbal Formulation

Objective: Stability representing the RP-HPLC method was established for synchronized quantification of Tigecycline and its impurities. This method was confirmed for its applicability to both tablet dosage and bulk drug forms. Methods: Intended for an isocratic elution, a mobile phase containing methanol: 10 mmol Triethylamine Buffer mixture (75:25 v/v, pH 6.1) was used at 1 ml/min flow rate and Agilent ZORBAX Eclipse XDB C18 (250 mm × 4.6 mm, 5 μm) column. Results: At 231 nm as wavelength, high-pitched peaks of Tigecycline (Tig) and its impurities (1and2) were detected at 6.55, 8.73 and 4.87 min correspondingly. The linearity of tigecycline and its impurities (impurity-1 and 2 and) were estimated with ranging from 75–450 µg/ml for Tigecycline and 1–6 µg/ml for both impurity 1 and 2. The corresponding recognition limits (LOD and LOQ) of the tigecycline and its impurities were originated to be (1.37,0.047 and 0.071 µg/ml) and (4.15, 0.143 and 0.126 µg/ml). Conclusion: The technique was effectively stretched for stability signifying studies under different stress conditions. Justification of the method was done as per the current ICH guidelines.

Section: Linearitymentioning

confidence: 77%

“…The technique is penetrating as the LOQ and LOD values were originated to be lower the specified limit. The following formula is used for the calculation of LOD and LOQ (26). LOD and LOQ values are lower in the present study compared to the other studies [8,9].…”

Section: Lod and Loqmentioning

confidence: 78%

Simultaneous Determination of Tigecycline and Its Potential Impurities by a Stability-Indicating Rp-HPLC-Uv Detection Technique

KISHORE¹,

Ramana²

2022

Potential Activity of Kaempferol as Anti-Parkinson’s; Molecular Docking and Pharmacophore Modelling Study

MAHFUDIN,

SUBARNAS,

WILAR

et al. 2023

Objective: This study examined molecular docking and pharmacophore modeling to evaluate the potential antiparkinson activity of Kaempferol on various types and classes of receptors. Methods: The molecular docking was performed on various classes of receptors, namely transcription factor Nrf2, A2A Adenosine, and catechol-O-methyl transferase, using auto dock 4.0.1 software. Results: Kaempferol exhibited potential effects on two of the three tests (A2A adenosine and COMT receptors) as indicated by the lowest free energy binding values (-5.42 kcal/mol,-7.16 kcal/mol, and-8.33 kcal/mol, respectively). Kaempferol also had lower inhibitory constant values on transcription factor Nrf2, A2A adenosine, and COMT receptors (106.06 µM, 5.63 µM, and 779.51 nM, respectively). Kaempferol and the natural ligand had similar functional groups according to the critical components of the interaction between amino acid residues. The pharmacophore modeling revealed that hydroxyl functional groups strongly interact with crucial amino acid residues of the receptors. Conclusion: This study concludes that kaempferol is a potential antiparkinson agent against multiple receptors.

A Stability, Accuracy, and Robustness Representing Liquid Chromatographic Method for the Quantification of Zanubrutinib and Its Specified Impurities

KANTHETI,

RAJU

2023

Objective: An innovative RP-HPLC isocratic method was established and then validated using Zanubrutinib and its specified impurities (Impurity-1, Impurity-2, Impurity-3, Impurity-4, and Impurity-5). Methods: In this method, effective chromatographic separation was given an X-Bridge Phenyl column measuring 250 mm x 4.6 mm, packed column with 5μ as a particle size. Acetonitrile, 1% Ortho Phosphoric acid (pH: 2.7), and methanol in the volume ratios 40, 40, and 20 were utilized as a mobile phase at room temperature with an optimized 1.0 ml/min flow rate. Wavelength was detected at 225 nm by using a PDA detector. Results: Retention times of zanubrutinib and its specified impurities were recorded at 13.284, 4.730, 6.816, 9.583, 10.726, and 12.287. Moreover, other parameters USP tailing is good, USP plate count above 4000, and USP resolution is greater than are equal to 2. The Obtained peaks are homogeneous, hence the purity angle is less than the purity threshold and No Purity Flag. According to ICH guidelines, this method was validated. Zanubrutinib (5-75 µg/ml), their quantified impurity-1, impurity-2, impurity-4, impurity-5 (0.1-1.5 µg/ml), and impurity-3 (0.1-1.5 µg/ml) are proved through linearity method in between LOQ to 75 quantified levels. The % recovery was present between 100.18-95.85, 103.15-93.80, which is a good and acceptance range (amongst 85% and 115%) for drug and specified impurities. The limit of quantitation (LOQ) and limit of detection (LOD) values were assessed for zanubrutinib and its specified impurities were tabulated. These values were calculated using slope (σ) and standard deviation (SD) methods. Method precision (M. P.) and Intermediate (I. P.) Intermediate (I. P.) precision was estimated by evaluating several (six) samples of a similar batch as per the planned technique on the day and the next day, using different columns and systems. Robustness information significantly affects the resolution between Zanubrutinib and specified impurities. The remaining parameters do not impact the parameter’s system suitability. Conclusion: Hence this method was chosen for common analysis. Finally, the system-suitable parameters and validation parameters values are acceptable limits.