Development and validation of stability indicating RP-HPLC method for Simultaneous Estimation of Imipramine Hydrochloride and Diazepam in combined pharmaceutical dosage form

Authors

  • P.Pydiratnam Avanti Institute of Pharmaceutical Sciences, Vizayanagaram Dist, Andhra Pradesh, India
  • T. Santosh Kumar Pharmaceutical Research & Development Laboratory, Corpuscle Research Solutions, Visakhapatnam-530003, India.
  • S Satyanarayana Avanti Institute of Pharmaceutical Sciences, Vizayanagaram Dist, Andhra Pradesh, India

Keywords:

Diazepam Imipramine HCl, RP HPLC, anxiolytic, Antidepressant

Abstract

A simple, precise, and stability indicating high performance liquid chromatography (HPLC) method was developed and validated for the simultaneous determination of Imipramine hydrochloride and Diazepam in pharmaceutical dosage form.

Materials and Methods: The method involves the use of easily available inexpensive laboratory reagents. The separation was achieved on Phenomenex Prodigy C-18 column (150*4.6 mm, i.d., 5 ?m particle size) with isocratic flow with UV detector. The mobile phase at a flow rate of 1.0 mL/min consisted of methanol and 0.1%v/v ortho phosphoric acid (pH 3) in the ratio of 70:30 v/v.

Results: A linear response was observed over the concentration range 5.00-50.00 ?g/mL of diazepam and the concentration range 5.00-50.00 ?g/mL of Imipramine HCl. Limit of detection and limit of quantitation for Imipramine were 2.73 ?g/mL and 1.27 ?g/mL, and for Diazepam were 1.80 ?g/mL and 1.98 ?g/mL, respectively. The method was successfully validated in accordance to ICH guidelines acceptance criteria for linearity, accuracy, precision, specificity, robustness.

Conclusion: The analysis concluded that the method was selective for simultaneous estimation of Imipramine HCl and Diazepam can be potentially used for the estimation of these drugs in combined dosage form.

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References

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Published

2013-10-31
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How to Cite

P.Pydiratnam, T. Santosh Kumar, and S. S. S Satyanarayana. “Development and Validation of Stability Indicating RP-HPLC Method for Simultaneous Estimation of Imipramine Hydrochloride and Diazepam in Combined Pharmaceutical Dosage Form”. International Journal of Pharmaceutics and Drug Analysis, vol. 1, no. 1, Oct. 2013, pp. 13-24, https://ijpda.com/index.php/journal/article/view/4.

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