A rapid and simple high-performance thin layer chromatography (HPTLC) method with densitometry at 230 nm was developed and validated for simultaneous determination of diphenhydramine hydrochloride (DPH) and naproxen sodium (NPS) from pharmaceutical preparation. The separation was carried out on aluminum plates precoated with silica gel 60 F254 using mobile phase toluene:methanol:glacial acetic acid (7.5:1:0.2, v/v/v). The linearity range lies between 200 and 1200 ng/band for DPH and 1760 and 10,560 ng/band for NPS with correlation coefficients of 0.994 and 0.995, respectively. The Rf value for DPH is 0.20 ± 0.05 and for NPS is 0.61 ± 0.06. % Recoveries of DPH and NPS was in the range of 99.70%–99.95% and 99.63%–99.95%, respectively. Limit of detection value for DPH was 13.21 ng/band and for NPS was 8.03 ng/band. Limit of quantitation value for DPH was 40.06 ng/band and for NPS was 24.34 ng/band. The developed method was validated as per ICH guidelines. In stability testing, DPH was found unstable to acid and alkaline hydrolysis, and DPH and NPS were found unstable to oxidation, whereas both the drugs were stable to neutral and photodegradation. The proposed method was successfully applied for the routine quantitative analysis of dosage form containing DPH and NPS.
A B S T R A C TDespite the popularity of orally fast disintegrating tablets (FDTs), their formulation can sometimes be challenging, producing tablets with either poor mechanical properties or high disintegration times. The aim of this research was to enhance the properties of FDTs produced by direct compression to have both sufficient hardness to withstand manual handling, and rapid disintegration time. General multilevel factorial design was applied to optimise and evaluate main and interaction effects of independent variables (i) disintegrant concentration, (ii) % filler (Disintequick MCC-25) to mannitol on the responses hardness, tensile strength and disintegration time. In this experiment mannitol was used as a diluent, Disintequick MCC-25 (to best of our knowledge there is no publication available yet for its use with FDTs) was termed in this study as a filler and croscaremellose sodium was used as the superdisintegrant. ) and friability of 2.2%; (ii) 7% or 10% w/w disintegrant with 33.33% w/w filler to mannitol, showing disintegration time of 84 s (for 7% disintegrant) and 107 s (for 10% disintegrant), hardness of 73.86 N (for 7% disintegrant) and 72.68 N (for 10% disintegrant) and friability of 1.44 (for 7% disintegrant) and 1.15% (for 10% disintegrant).
A simple, sensitive, rapid, robust and reproducible method for the determination of Quetiapine Hemi Fumarate (QHF) in bulk and Pharmaceutical Formulation (Tablets) was developed using Reverse Phase High Performance Liquid Chromatographic method (RP-HPLC). The RP-HPLC analysis was performed isocratically on XTERRA C18 (4.6 X 150 mm), analytical column using a mobile phase consisting of Acetonitrile and methanol in the ratio of 60 : 40 v / v, with a flow rate of 1 ml / min. The analyte was monitored with UV detector at 290 nm. The developed method Quetiapine hemi fumarate elutes at a run time of 10 minutes. The proposed method is having linearity in the concentration range from 20 to 100 μg / mL of Quetiapine hemi fumarate. The present method was validated with respect to system suitability, linearity, precision, limit of detection (LOD) and limit of quantification (LOQ), accuracy (recovery), and robustness as per ICH Guidelines. The proposed method can be readily utilized for bulk drug and pharmaceutical formulations.
Two specific spray reagents for the detection of the commonly misused carbamate insecticide carbaryl have been developed, viz., (i) 1% mlVcopper(l1) chloride followed by 0.1% ammonium metavanadate and (ii) 0.5% mlVpotassium hexacyanoferrate(ll1) in 0.5% m/Vsodium hydroxide. The former reagent has relatively higher sensitivity for the breakdown product of carbaryl, 1 -naphthol, whereas the latter has the same sensitivity for both carbaryl and I-naphthol, ca. 1 pg.
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