Nadiad

A VALIDATED STABILITY- INDICATING HIGH PERFORMANCE LIQUID CHROMATOGRAPHIC METHOD FOR DARUNAVIR ETHANOLATE IN TABLET DOSAGE FORM

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ABOUT AUTHORS:
Palak G. Chaudhary1*, Bhavini N. Patel1, Chhagan N. Patel2
1Department of Quality Assurance,
2Department of Pharmaceutical Chemistry
Shri Sarvajanik Pharmacy College, Mehsana, Gujarat, India.
*palakc24@gmail.com

ABSTRACT
High performance liquid chromatographic method was developed and validated for the determination of Darunavir Ethanolate in tablet dosage form. The method was carried out on a Phenomenex luna C18 Column (150 × 4.6 mm id, 5µ) maintained at 30oC. The mobile phase consisted of water-acetonitrile (60 + 40, v/v) pumped at a flow rate 1.0 mL/min. Photo diode array detection was at 265 nm. The chromatographic separation was obtained with a retention time of 11.8 min, and the method was linear in the range of 1-30 µg/mL (r2 = 0.9997). The specificity and stability indicating capability of the method was proven through forced degradation studies, which also showed that there was no interference of the excipients. The method was validated for linearity, precision, accuracy, robustness, specificity, limit of detection and limit of quantitation. The developed method, after being validated was successively applied to the analysis of tablet formulations. The drug could be effectively separated from different degradation products and hence the method can be used for stability analysis.

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PREPARATION AND CHARACTERIZATION OF NAPROXEN SODIUM AGGLOMERATES BY SPHERICAL CRYSTALLIZATION TECHNIQUE

About Authors:
Akash M Patel*, Jitul B Patel
*Faculty of Pharmacy, Dharmsinh Desai University,
Nadiad-387001, Gujarat
*aku.pharmacy@gmail.com

Abstract
The purpose of this research work to prepare agglomerate of naproxen sodium for enhanced dissolution and improved physicochemical properties. Spherical crystallization technique was used to prepare agglomerates of naproxen sodium. Solubility of naproxen sodium was determined in different solvents for find out good solvent and bad solvents. Agglomerates of naproxen sodium alone and with incorporation of different polymer were prepared and stirring rate was also optimized. Prepared agglomerates were characterized for particle size, in-vitro drug dissolution study, % compressibility and different tableting parameters. Prepared agglomerates were characterized by DSC, XRD, FT-IR, and SEM. Results of in-vitro dissolution study indicated that agglomerates prepared by spherical crystallization were having higher dissolution than the naproxen sodium alone. Incorporation of polymers like PEG 400 and PVP K30 was also improved tableting characteristics as well as in vitro dissolution than agglomerates without incorporation of polymers. In conclusion, agglomeration of poorly water soluble drugs like naproxen sodium by spherical crystallization technique was successfully implemented for dissolution enhancement.

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Karnataka Antibiotics & Pharmaceuticals Ltd., (KAPL) Bangalore is a Government Enterprise.  From a modest beginning in 1984, KAPL has grown from strength to strength in the areas of manufacturing and marketing of various life saving and essential drugs. With an ISO accredition from KPMG, Netherlands, KAPL is recognised for its total commitment to quality and services in domestic and international markets. On profit from inception, KAPL facilities are approved by many international clients.

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