www.wjpr.net Vol 6, Issue 11, 2017. 878 Manohar et al. World Journal of Pharmaceutical Research IMPURITY PROFILE AND VALIDATION OF PHARMACEUTICAL (API) BULK DRUG Champa P. Maurya 1 and Dr. Manohar V. Lokhande 2 * 1 Research Scholar, Department of Chemistry, Jagdish Prasad Jhabarmal Tibrewala University, Jhunjhunu-333001, Rajasthan, India. 2 *Department of Chemistry, Sathaye College, Vile Parle (E), Mumbai-400057, Maharashtra, India. 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 R 2 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. World Journal of Pharmaceutical Research SJIF Impact Factor 7.523 Volume 6, Issue 11, 878-887. Research Article ISSN 2277– 7105 *Corresponding Author Dr. Manohar V. Lokhande Department of Chemistry, Sathaye College, Vile Parle (E), Mumbai-400057, Maharashtra, India. Article Received on 29 July 2017, Revised on 19 August 2017, Accepted on 09 Sep. 2017 DOI: 10.20959/wjpr201711-9604