Validated Stability Indicating Rp-Hplc and Hptlc Methods for the Determination of Zanamivir in Bulk and Pharmaceutical Formulation| Chapter 9 | Challenges and Advances in Pharmaceutical Research Vol. 9

 The objective of the work is to develop a natural, precise, correct, validated stability signifying RP-HPLC and HPTLC method for the determination of Zanamivir all-inclusive and capsule dosage form. The HPLC break-up was achieved on Agilent TC C18 (2) 250 x 4.6 mm, 5 μ column utilizing mobile phase arrangement of methanol - 0.02 M phosphate safeguard, pH 5, 50:50 (V/V). The flow rate was kept constant at 1 ml/brief time period at room temperature. At 230 nm, UV discovery was used to quantify. Zanamivir had a memory time of 3.6 minutes. The result got with the detector reaction was found expected linear in the concentration range of 2-12 μg/ml. The system employed TLC aluminium plates precoated with silica coagulate 60F-254 as the stationary chapter. The solvent system involved Chloroform: methanol: acetic acid (4.5:0.5:0.3v/v) and before scanned .The system was found to present compact spot for Zanamivir (Rf value of 0.29 ± 0.02). The undeviating regression analysis dossier for the calibration plots showed good friendship with r2=0.9999 ± 0.0001 in the aggregation range 500-3000 ng/spot. The linearity, range, precision, veracity, detection, and quantitation limitations of the submitted techniques, in addition to their analytical performance, were statistically ratified. The suggested methods commit successfully separate Zanamivir from allure degradation products when it was bear hardship various stress settings; suitable way, they were regarded as active stability-indicating methods. It is concluded that this technique maybe used for zanamivir portion of drug or other consumable forms and bulk drug routine quality control.

Author(s) Details:

C. H. Bhirud,
PRES’S College of Pharmacy (For Women), Chincholi, Nashik, India.

Please see the link here: https://stm.bookpi.org/CAPR-V9/article/view/8679

Validation, Quantification and Stress Degradation Studies of Lenvatinib Mesylate in Bulk Drug and Pharmaceutical Dosage Forms Using Ultra Performance Liquid Chromatography| Chapter 3 | Current Aspects in Pharmaceutical Research and Development Vol.9

 The goal of this work was to use UPLC to establish a new method for quantifying Lenvatinib mesylate in bulk drug and pharmaceutical dose form, as well as to validate the method and conduct stress degradation experiments on the drug.

UPLC HSS C18 (100 mm x 2.1mm, 1.8m) column, mixture of 0.1 percent OPA and Acetonitrile (50:50) mobile phase run on an isocratic mode at a flow rate of 0.3ml/min, 240nm detection wavelength, and column oven temperature maintained at 30oC were the optimised chromatographic conditions for drug elution.

Lenvatinib's retention time was found to be 1.24 minutes. In compliance with ICH requirements, the suggested method was validated for several validation parameters. In the concentration range of 2.5g/ml – 15g/ml, the technique followed Beer's law with a correlation coefficient of 0.9996. The percent RSD and percent recovery, respectively, were found to be 0.4 and 99.66 percent – 100.30 percent. It was discovered that the procedure was accurate, precise, particular, linear, rugged, and robust. The medication was subjected to a variety of stress conditions, including acidic, basic, peroxide, neutral, photolytic, and thermal. The net degradation was found to be within acceptable bounds.

Conclusion: The devised approach for estimating Lenvatinib in pharmaceutical dosage form can be used for routine analysis.

Author(s) Details:

Jahnavi Bandla,
Department of Pharmaceutical Analysis and QA, Faculty of Pharmacy, Vishnu Institute of Pharmaceutical Education and Research, Narsapur, Medak-502313, Telangana, India.

S. Ganapaty,
Department of Pharmacognosy and Phytochemistry, GITAM Institute of Pharmacy GITAM University, Rushikonda, Visakhapatnam-530045, Andhra Pradesh, India.

Please see the link here: https://stm.bookpi.org/CAPRD-V9/article/view/5963#