ABSTRACT

A rapid and precise reverse phase high performance liquid chromatographic method has been developed for the validated of Lacosamide, in its pure form as well as in tablet dosage form. Chromatography was carried out on a Symmetry C18 (4.6 x 150mm, 5 mm) column using a mixture of, Methanol and phosphate buffer (65:35 v/v) as the mobile phase at a flow rate of 0.7 mL/min, the detection was carried out at 215nm. The retention time of the drug was 2.56±0.02 min. The method produced linear responses in the concentration range of 10-60 mg/ml of Lacosamide. The method precision for the determination of assay was below 2.0%RSD. The method is useful in the quality control of Bulk and pharmaceutical formulations.

Key words: Lacosamide, RP-HPLC, Validation.

ABSTRACT

Two simple, accurate, rapid and sensitive methods (A and B) have been developed for the estimation of Promethazine Hydrochloride in its pharmaceutical dosage form. The method A and B are based on the formation of chloroform extractable complex of Promethazine Hydrochloride with Bromothymol Blue (method A) and bromocresol green (method B), which shows absorbance maxima at 416 nm and 414 nm respectively. The absorbance-concentration plot is linear over the range of 4-20 mcg/ml and 2-10 mcg/ml for method A and B respectively. Results of analysis for all the methods were validated statistically and by recovery studies. The proposed methods are economical and sensitive for the estimation of Promethazine Hydrochloride in bulk drug and in its tablet dosage form.

Keywords: Ultraviolet-Visible Spectrophotometry, Promethazine Hydrochloride, Bromocresol Green (BCG).

ABSTRACT

A rapid and precise reverse phase high performance liquid chromatographic method has been developed for the validated of Rufinamide, in its pure form as well as in tablet dosage form. Chromatography was carried out on a Symmetry C18 (4.6 x 150mm, 5 m) column using a mixture of, Methanol and Water (50:50 v/v) as the mobile phase at a flow rate of 1 mL/min, the detection was carried out at 220nm. The retention time of the drug was 5.20±0.02 min. The method produced linear responses in the concentration range of 10-60 mg/ml of Rufinamide. The method precision for the determination of assay was below 2.0%RSD. The method is useful in the quality control of Bulk and pharmaceutical formulations.

Key words: Rufinamide, RP-HPLC, Validation.

ABSTRACT

Zero-order and Area Under Curve [AUC] UV-Spectrophotometric methods have been developed and validated for the estimation of Tenofovir disproxil fumarate in bulk and its tablet formulations. The solutions of standard and sample were prepared in water. Tenofovir disproxil fumarate was estimated at 260 nm and for the zero order UV-Spectrophotometric methods, respectively, while area under curve for the zero order spectrum of Tenofovir disproxil fumarate between 250 nm to 270 nm was measured for AUC method. Beer’s law was obeyed in the concentration range of 5 - 30 μg / ml with r2 value 0.999 for zero order . In AUC method, beer’s law was obeyed in the concentration range of 5-30 μg / ml with r2 value 0.999. These methods were tested and validated for various parameters according to ICH guidelines. The proposed methods were successfully applied for the determination of Tenofovir disproxil fumarate in tablet formulations.

Keywords: Tenofovir disproxil fumarate, UV-Spectrophotometric methods, beer’s law.

ABSTRACT

The article highlights on the development of validated stability indicating methods for active pharmaceutical ingredients and formulations. International Council on Harmonization (ICH) prescribed different stress test conditions and degradation studies for testing the stability of active pharmaceutical ingredients and formulations is emphasized. A systematic approach for the development of stability indicating chromatographic methods is also discussed.

Key words: Stability indicating methods, Active pharmaceutical Ingredients, Formulations.

ABSTRACT

Ultra Performance Liquid Chromatography (UPLC) is a relatively new technique giving new possibilities in liquid chromatography, especially concerning decrease of time and solvent consumption. UPLC chromatographic system is designed in a special way to withstand high system back-pressures. The quality control analyses of various pharmaceutical formulations are transferred from HPLC to UPLC system. The separation on UPLC is performed under very high pressures (up to 100 MPa) but it has no negative influence on analytical column or other components of chromatographic system. Separation efficiency remains maintained or is even improved by UPLC. This review introduces the theory of UPLC, and summarizes some of the most recent work in the field.

Keywords: UPLC, Ultra performance liquid chromatography, High pressure.

ABSTRACT

This article presents a review on chromatography and method validation applied to the determination of various pharmaceuticals is discussed. It describes about various Chromatographic techniques and its method validation. Also it briefly describes about the different types of chromatographic techniques and HPLC method validation parameters. The primary objective of validation is to form a basis for written procedure for production and process control which are designed to assure that the drug products have the identity, strength, quality and purity they purport or are represented to possess quality, safety and efficacy must be designed to build into the product. Each step of the manufacturing process must be controlled to maximize the probability that the finished products meet all quality and design specification.

Keywords: Chromatography, HPLC, Method Validation, Method development, ICH Guidelines.

ABSTRACT

Quantitative determination of active pharmaceutical ingredient and its degradative products in biological fluids is a challenging task for an analyst due to difficulties and uniqueness of the sample. A systematic study of pharmaceutical products on human subjects whether patients or non-patient volunteers in order to discover or verify the clinical, pharmacological (including pharmacodynamics/ pharmacokinetics), adverse effects, with the object of determining their safety or efficacy and correcting plasma level with therapeutic action.

Keywords: Bioanalytical method, Recent Analytical Techniques, LC-MS/MS.