Bioanalytical and Analytical Method Development and HPTLC Method Validation for Pharmaceutical Dosage Formulation

Abstract

Dr. Shailesh B. Patil and Prof. Jitendra D. More

The literature survey determined a need to improve the bioavailability of a very effective molecule viz. Curcumin. Attempts are despite the fact that happening with the utilization of diverse techniques to the molecule are its very low solubility in water. Many marketers like Cyclodextrin, PVP, Gelucire 44/14, Gelucire 50/thirteen, and, Cellulose ace- tate mannitol has been used to put together stable dispersion for oral dosage paperwork. Smooth and, specific HPTLC methods had been advanced for the HPTLC Bioanalytical approach the prevailing statement is deliberate to prepare the sturdy distribution of Gelucire 44/14 and, Curcumin improves solubility and similarly formulate into Sodium alginate Curcumin Floating Beads (SCFB) for oral use. HPTLC technique became advanced and, showed for the determination of curcumin from serum samples inside the following manner 3albino Wistar rats had been fed with a widespread pellet eating regimen and maintained at a temperature of (25 ± zero. Five° C RH =30%), and 12hrs. Brightness /dim cycle) had been used intended for the have a take a look at.

The technique turns into tailor-made to investigate tablets in their business dosage form (SCFB) without interfering from ingredient. Chromatographic division is completed in excess of TLC that has been coated tableware Merck, Darmstadt, Germany, (“60 F254, 20centimeter 10 cm, 250 m thinness”) via a linear-line downhill method the use of the mobile phase constituting toluene: chloroform: methanol: acetic acid (five: four: zero. 5: zero. 5) changed into utilized for the approach improvement. Detection and, quantification have been completed at 426 nm through UV-Spectrophotometer assessment. The investigative ordinary performance of the proposed HPTLC technique become installed consistent by means of the ICH recommendations concerning precision, linearity, quantitation limits, accuracy, detection, quantita- tion limits, specificity, and robustness. The calibration curve has been linear with the boundaries of two hundred–one thousand ng/spot for Curcumin with relationship coefficients (r2) > 0.9998. The boundaries of detection had been 30 ng/spot for Curcumin. The confirmed HPTLC approach was efficiently applied to the determination of Curcumin within the business polyhedral components.

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