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Abstract

IMPURITY PROFILE AND VALIDATION OF PHARMACEUTICAL (API) BULK DRUG

Champa P. Maurya and Dr. Manohar V. Lokhande*

ABSTRACT

Pharmaceutical API bulk drug containing three impurities were found during the analysis. High performance liquid chromatography method was developed and validated for the Impurities of albuterol in bulk and capsules dosage forms. The separation was achieved on HPLC Columns (C-104) and (C-118) analytical column (250 mm × 4.6 mm i.d., 5.0 μm) using Acetonitrile (HPLC Grade), Methanol (HPLC Grade) in the ratio 50:50 v/v as mobile phase and at a flow rate of 1.0 mL/min. Detection was carried out using a UV detector at 302nm. The total chromatographic analysis time per sample was about 7.1 min and for impurities 11.6, 12.2 and 12.7. The method was validated for accuracy, linearity, LOD, LOQ and stability of analytical solutions. Validation studies demonstrated that, this HPLC method is simple, specific, rapid, reliable and reproducible. The standard curve was linear over the concentration range of 25-150μg/mL with R2 close to (0.9998). The limit of detection (LOD) and limit of Quantitation (LOQ) obtained 0.025μg/mL and 0.05μg/mL respectively. The developed and validated method was successfully applied for the quantitative analysis of albuterol capsules. The high recovery and low relative standard deviation confirm the suitability of the proposed method for the determination of albuterol in capsule dosage form.

Keywords: Accuracy, Linearity, LOD, LOQ, HPLC Techniques and Stability in Analytical Solution.


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