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Drug Dissolution: Requirements and Profile Comparison01:14

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The acceptance criteria for dissolution profile data are anchored in Q values, representing the percentage of drug dissolved within a specified period. This assessment unfolds in three stages:First Stage: The test passes if all six drug dosage units are equal to or greater than Q plus 5%; otherwise, the sample proceeds to the second stage.Second Stage: The average of twelve units must be equal to or greater than Q, with no unit falling below Q - 15% to pass; if not, it progresses to the final...
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Product specifications define the acceptable quality of a pharmaceutical product by ensuring identity, purity, potency, and strength. These specifications serve as benchmarks during development, manufacturing, and post-approval quality control. Clinically relevant specifications are particularly important because they directly relate to a drug's safety and efficacy in clinical use.Dissolution studies are critical biopharmaceutic tools that link in vitro behavior to in vivo performance. They...
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Quality by Design Approach for Simultaneous Estimation of Doxycycline Hyclate and Curcumin by RP-HPLC Method.

C Dhal1, F J Ahmad1, A Chauhan2

  • 1Department of Pharmaceutics, Jamia Hamdard University, New Delhi-110 062, India.

Indian Journal of Pharmaceutical Sciences
|March 22, 2016
PubMed
Summary
This summary is machine-generated.

A new high-performance liquid chromatography method accurately measures doxycycline hyclate and curcumin simultaneously. This validated analytical technique offers a reliable approach for quantifying these compounds in pharmaceutical analysis.

Keywords:
ICHcurcumindoxycycline hyclateperiodontitisquality by designrelative standard deviation

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Area of Science:

  • Analytical Chemistry
  • Pharmaceutical Analysis

Background:

  • Doxycycline hyclate is a widely used antibiotic.
  • Curcumin, a natural compound, possesses various therapeutic properties.
  • Simultaneous quantification of both compounds is essential for pharmaceutical research and quality control.

Purpose of the Study:

  • To develop and validate a simple, rapid, reliable, and robust reversed-phase high-performance liquid chromatographic (RP-HPLC) method.
  • To achieve simultaneous estimation of doxycycline hyclate and curcumin.
  • To optimize the method using Quality by Design (QbD) principles.

Main Methods:

  • Utilized a Waters Sunfire C8 column (250×4.6 mm, 5.0 μm particle size).
  • Employed a mobile phase of potassium dihydrogen phosphate buffer (50 mM, pH 6.5±0.1) and methanol (70:30 v/v) at a flow rate of 0.85 ml/min.
  • Monitored effluents at 400 nm at ambient temperature (28°C).
  • Optimized using Minitab software version 16.

Main Results:

  • Achieved well-separated peaks within 10 minutes.
  • Demonstrated linearity over concentration ranges of 200-700 μg/ml for doxycycline hyclate and 8-28 μg/ml for curcumin.
  • Determined low detection and quantitation limits for both analytes.
  • Method validation confirmed accuracy, precision, specificity, system suitability, and robustness.

Conclusions:

  • A robust and validated RP-HPLC method for simultaneous estimation of doxycycline hyclate and curcumin has been successfully developed.
  • The method adheres to International Conference on Harmonization (ICH) guidelines.
  • The optimized method is suitable for routine quality control and pharmaceutical analysis.