Migration study of optical brighteners from polymer packing materials to jam squeeze and fruit drink by spectrofluorimetry and RP-HPLC methods.

Optical brighteners are commonly used to modify the appearance and to improve polymer properties of packaging. They are not chemically bound to polymers and able to migrate from packaging into the foods. These migrants are potentially harmful to human health. In concern with human safety an approach was made to analyze three optical brighteners such as diphenylbutadiene, Uvitex-OB, benzophenone in commercial fruit juice and jam. The migration level of these optical brighteners from low density poly ethylene packaging into fruit juice and jam was studied. Two optimized and validated analytical techniques such as spectrofluorimetry and high performance liquid chromatography with photo diode array detector used for migration study. Both methods have shown high correlation coefficients (>0.999), over a concentration range of 0.1-3.2 µg/mL, 0.1-1 µg/mL, 0.05-3.2 µg/mL for diphenylbutadiene, Uvitex-OB and benzophenone respectively. The preliminary studies confirm that the low density poly ethylene layer taken for study contained of diphenylbutadiene and the other two were absent. The migration level of diphenylbutadiene was studied at room temperature and different elevated temperature from 30 °C to 60 °C for up to 3 weeks. At room temperature no migration of diphenylbutadiene was observed where as at higher temperature migration could be observed. The maximum quantity of diphenylbutadiene migrated was found to be 0.0462 mg/kg from tetrapak, and 0.0382 mg/kg from jam squeeze after 3 weeks treatment at 60 °C. The migration of diphenylbutadiene was found to be less than allowable concentration during the study period.

Ion Pair-HPLC Method for the Simultaneous Estimation of Quinapril and Hydrochlorothiazide in Tablets.

A simple, precise and rapid HPLC method has been developed and validated for the estimation of quinapril and hydrochlorothiazide simultaneously in combined dosage form. The mobile phase used was a mixture of 0.1% v/v triethylamine (pH 3.5), containing 1 mM of hexane sulphonic acid: acetonitrile (30:70% v/v). The detection of quinapril and hydrochlorothiazide was carried out on photo diode array detector at 220 nm. Results of the analysis were validated statistically and by recovery studies. The proposed method can be successfully used to determine the drug contents of marketed formulation.

Simultaneous LC determination of tizanidine and rofecoxib in tablets.

A reverse phase high performance liquid chromatographic method to determine tizanidine (TZ) and rofecoxib (RF) in combination is proposed and applied to the pharmaceuticals. This method allows the determination of 0.1-0.5 microg/ml of TZ and 1.2-6.0 microg/ml of RF along with 10 microg/ml of nimesulide (internal standard), in a mobile phase consisting of 1% (v/v) triethylamine (pH adjusted to 2.5 using dilute orthophosphoric acid):acetonitrile in the ratio 55:45% (v/v). Detection wavelength of 303 nm and flow rate of 0.8 ml/min were fixed for the study. The limit of detection (LOD) for TZ and RF were found to be 10 and 1 ng/ml, respectively. The limit of quantification (LOQ) for TZ and RF were found to be 80 and 12 ng/ml, respectively. The amount of drug present in the tablet and the recovery studies were also carried out. The % R.S.D. of recovery studies for TZ and RF were found to be 0.0673 and 0.0146, respectively. The method is validated for accuracy, precision, ruggedness and robustness.

Determination of repaglinide in pharmaceutical formulations by HPLC with UV detection.

A simple, precise and rapid RP-HPLC method was developed for the determination of repaglinide in pharmaceutical dosage forms. The method was carried out on a Shim-pack, RP-C18 column using a mixture of methanol: 0.1% v/v triethylamine (pH adjusted to 7 with orthophosphoric acid) and detection was done at 235 nm using nimesulide as internal standard. The linearity range was 0.1 to 0.5 microg/ml. The intra-day and inter-day precision were in the range of 0.48 to 1.01 and 0.15 to 1.15, respectively.

Simultaneous determination of aspirin and isosorbide 5-mononitrate in formulation by reversed phase high pressure liquid chromatography.

A simple, precise and rapid reversed phase HPLC method was developed for the simultaneous estimation of aspirin (AS) and isosorbide 5-mononitrate (ISM) in combined formulation. The method was carried out on a Thermo Quest C18 column using a mixture of water:methanol (water pH adjusted to 3.4 using dilute orthophosphoric acid) and detection was carried out at 215 nm using chlorzoxazone as internal standard. Both the drugs showed linearity in the range of 2-10 microg/ml and limits of quantification was found to be 4 and 40 ng/ml for AS and ISM, respectively.

Reversed-phase HPLC method for the estimation of acetaminophen, ibuprofen and chlorzoxazone in formulations.

A simple, precise and rapid reversed-phase HPLC method was developed for the simultaneous estimation of acetaminophen, ibuprofen and chlorzoxazone in formulations. The method was carried out on a Kromasil(R) C(8) column using a mixture of 0.2% triethylamine:acetonitrile (adjusted to pH 3.2 using dilute orthophosphoric acid), and detection was carried out at 215 nm using ketoprofen as internal standard. All these drugs showed linearity in the range of 2-10 mug ml(-1), and limits of quantification was found to be 10, 50 and 20 ng ml(-1) for acetaminophen, ibuprofen and chlorzoxazone, respectively.