International Journal of Pharmaceutical Chemistry and Analysis

59-64

Authors: Bulbul Purkait , Anup Sharma.

Arnica Montana extract, a natural limuloid contains about 59 ingredients out of which sesquiterpene lactones helenalin, and dihydrohelenalin, are considered significant medicinally active ingredients. Arnica Montana is commonly used in folk medicine, CAM, and Homeopathic drug as neurotropic, cardiotropic, Anti-inflammatory, Anti-bacterial, Anti-oxidant, Anti tumors, to control diabetes, etc. The plant is often misidentified with similar plants. Arnica Montana is now a protected endangered plant species. The commercially available crude ethanol extract and serial dilutions of Arnica Montana is studied for identification and characterization using Scanning Electron Microscope and FTIR. Keywords: Arnica Montana, Lactones, Scanning Electron Microscopy, Vibrational Spectroscopy, Serial Dilution.

74-83

Authors: Jagdish Kumar, Mymoona Akhtar, Chanda Ranjan, Gita Chawla

A series of 5-substituted phenyl-3-(thiophen-2-yl)-4, 5-dihydro-1, 2-oxazoles (2a-l) was synthesized by reacting appropriate chalcones of 2-acetyl thiophene with hydroxylamine hydrochloride in the presence of dry pyridine. The newly synthesized compounds were characterized by IR, 1HNMR, 13CNMR and mass spectral data. All the compounds were evaluated for their antidepressant and antianxiety activities in mice by forced swimming test and elevated plus maze method respectively. Test compounds and imipramine were administered intraperitoneally in antidepressant study at dose of 10 mg/kg. Similarly to study antianxiety activity, test compounds at the dose of 10 mg/kg and diazepam at the dose of 2 mg/kg were administered intraperitoneally. However, preliminary antidepressant screening of compounds (2a-l) revealed that none of the compounds showed antidepressant activity except for compound 2k which moderately (P<0.05) reduced the duration of immobility time. This compound was also tested in-vitro for its MAO inhibitory effect. Compound 2f showed highest antianxiety activity compared to diazepam and did not show neurotoxicity in rotarod test. The compounds were also studied for pharmacokinetic parameters and was observed that compound 2f displayed good ADME properties. Keywords: Thiophene, isoxazole, antianxiety and antidepressant.

97-101

Authors: P.S. Jain, N.K. Kale, K. M. Agrawal, N. G. Haswani, S.J. Surana

A HPTLC/Densitometric method has been developed for the determination of Guaifenesin (GFN) in bulk and pharmaceutical formulation. The estimation of drug was performed on HPTLC aluminium plates precoated with silica gel 60 RP-18 TLC F254 S using toluene: methanol: ethyl acetate: acetic acid (7:0.8:1.2:0.5 v/v/v/v) as mobile phase. The densitometric quantification for the drug was carried out at 274 nm. GFN obeyed linearity in concentration range 800 – 2800 ng/band with coefficient of correlation 0.999. The Rf for GFN was found to be 0.6 ± 0.02. The proposed method was applied for pharmaceutical formulation and % label claim for GFN was found to be 100.34  1.06. The method was validated for accuracy, precision and ruggedness. Accuracy of the method was checked by recovery studies at three different levels i.e. 80 %, 100 % and 120 %. The % recovery of GFN was found to be in the range of 99.48% - 100.68 %; the % RSD value was less than 2 indicates the accuracy of the method. The method was found to be precise as indicated by the inter-day, intra-day and repeatability analysis; showing % RSD less than 2. The results did not show any statistical difference between operators showing that developed method was rugged. GFN was subjected to acid and alkali hydrolysis, oxidation and thermal degradation. The drug undergoes degradation under acid-base conditions, hydrolysis, oxidation, photo degradation except dry heat degradation. This indicates that the drug is susceptible to acid and base. The degraded product was well resolved from the pure drug with significantly different Rf value. Statistical analysis proves that the method is repeatable, selective and accurate for the estimation of investigated drug. The proposed developed HPTLC method can be applied for the identification and quantitative determination of GFN in bulk drug and pharmaceutical formulation. Keywords: Guaifenesin, high-performance thin-layer chromatography (HPTLC), validation,stability, degradation.

108-112

Authors: Umang Shah, Tarang Talaviya, Anuradha Gajjar

A simple, novel, sensitive and precise validated spectrophotometric method was developed for simultaneous determination of Mebendazole (MBZ) and Levamisole Hydrochloride (LVM) in its tablet formulation. 1% H2SO4 in methanol was selected as a common solvent for estimation of MBZ and LVM. For first order derivative method, estimation of MBZ was carried out at 307nm (ZCP of LVM) and of LVM at 232.6nm (ZCP of MBZ). The linearity was obtained in the concentration ranges of 2-6 μg/mL for MBZ and 3-9 μg/mL for LVM with correlation coefficient(r2) value greater than 0.995 . The % RSD value for intraday & interday precision were less than 2. The detection limit and quantification limit were found to be 0.44 μg/mL and 1.34 μg/mL for MBZ and 0.14 μg/mL and 0.42 μg/mL for LVM, respectively. All the validation parameters were performed as per the ICHQ2 (R1) guidelines. The recovery study was carried out, results were 98.82 – 101.93 % for MBZ and 100.05-101.42% for LVM. So, the developed method could be applied for the routine quality control analysis of MBZ and LVM in combined tablet formulation. Keywords: Mebendazole, Levamisole Hydrochloride, First Order Derivatives, ICH guideline, Validation