Journal: Journal of Pharmacy Research

Article Id: JPRS-PA-00001361
Title: A Validated RP HPLC Method for Simultaneous Determination of Propranolol hydrochloride and Alprazolam in Bulk and in Pharmaceutical formulations
Category: Pharmaceutical Analysis
Section: Research Article
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  • Abstract

    The present work describes a new, simple, precise, and accurate RP-HPLC method for simultaneous estimation of propranolol hydrochloride and alprazolam in bulk and formulation. Chromatographic separation of the drugs was achieved on a Waters C18 column (250 × 4.6 mm, i.d. 5 ì) using acetonitrile: water (adjusted to pH 2.3 with ortho phosphoric acid) in the ratio of 60:40 v/v as mobile phase. Flow rate was 1.0 mL/min and the detection wavelength was 214 nm. The two drugs were satisfactorily resolved with retention time values 1.737 min and 3.810 min for propranolol and alprazolam, respectively. The method was validated in terms of accuracy, precision, linearity, and limit of detection, limit of quantitation, robustness, and ruggedness  as per ICH guidelines. Linearity was found to be in the range of 4 -30 µg/mL for propranolol hydrochloride and 0.05 – 0.375 mg/mL for alprazolam with significantly high value of correlation coefficient (r 2 = 0.9981 for propranolol hydrochloride and 0.9989 for alprazolam). The accuracy and reliability of the method was assessed by evaluation of precision (intra-day and inter-day precision % RSD was less than 2% for both alprazolam and propranolol hydrochloride), accuracy (100.01 % for propranolol hydrochloride and 99.84 % for alprazolam), and specificity, in accordance with ICH guidelines. The LOD and LOQ were found to be 0.4 ìg/mL and 1.2 ìg/mL for propranolol hydrochloride and 0.018 µg/mL and 0.05 µg/mL for alprazolam respectively. The proposed method can be used for the estimation of these drugs in combined dosage forms. 

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    Author(s) Name:

    G.Tulja rani*, D.Gowri shankar1, P.Kadgapathi2 and B. Satyanarayana3

    Affiliation(s) Name:

    *Department of Pharmaceutical Analysis, Sarojini Naidu Vanitha Pharmacy Mahavidyalaya, Exhibition Grounds, Nampally, Hyderbad- 500001, (A.P.) India
    1Department of Pharmaceutical Analysis and Quality Assurance, University college of Pharmaceutical sciences, Andhra University, Visakhapatnam 530003 (A.P.) India,2Hetero Drugs Ltd. Balanagar, Hyderabad- 500055, (A.P.) India, 3Neosun Biotech (India) Pvt. Ltd, Hyderabad- 500007 (A.P.) India.

    *Corresponding author.
    G.Tulja Rani M.Pharm. (Ph.D).
    Associate.Professor in Pharmaceutical Analysis
    Sarojini Naidu Vanitha Pharmacy Mahavidyalaya
    Exhibition Grounds, Nampally,
    Hyderabad –500001, India.

    Received on: 15-11-2010; Revised on: 18-12-2010; Accepted on:19-01-2011

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    Author:

    G.Tulja rani*, D.Gowri shankar1, P.Kadgapathi2 and B. Satyanarayana3

    Title:A Validated RP HPLC Method for Simultaneous Determination of Propranolol hydrochloride and Alprazolam in Bulk and in Pharmaceutical formulations
    Journal:Journal of Pharmacy Research
    Vol(issue):4 (February)
    Year:2011
    Page No: (358-360)
  • Experimental Methods Keywords

    Methodology:RP HPLC Method
    Research Materials:Propranolol hydrochloride, Alprazolam

Keywords

Propranolol hydrochloride Alprazolam and Simultaneous

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