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A simple and rapid reversed phase-high performance liquid chromatographic (RP-HPLC) method was proposed for simultaneous determination of imipramine hydrochloride and diazepam in pharmaceutical formulations. Elution was done utilizing methanol: water: 0.1%m sodium acetate (30:50:20 v/v/v) mobile phase with Chromosil C18 column in isocratic mode, at a flow rate of 1.0 ml/minute and detection wavelength of 243 nm. The measured retention times for imipramine hydrochloride and diazepam were 3.33±0.02 and 4.64±0.02 minutes, respectively. Validation of the method was established from linearity, robustness and recovery studies. Linearity was measured in the range 5-50 µg/ml for imipramine hydrochloride (r2=0.999) and in the range 2-20 µg/ml for diazepam (r2=0.9994), respectively. Satisfactory validation was also obtained from recovery (100.95-101.52% for imipramine hydrochloride and 99.47-100.33% for diazepam) studies, intra-day and inter-day precision (<2%) and robustness results. The reported method was the first study for quantitative determination of these drugs in combination and could be employed to investigate them in tablet dosage form in bulk.

Keywords: Imipramine HCL; Diazepam; RP-HPLC; UV detection; Tablet dosage form.

Imipramine hydrochloride (IPM), a tricyclic antidepressant belongs to anti-parkinsonian category [1]. Its chemical name is 10,l1-dihydro-5Hdibenz[b,f]azepine-5-(dimethylaminopropy1) hydrochloride. The molecular formula is C19H24N2.HCl and 316.9 gm/mol is the molar mass. It is officially recognized in Indian Pharmacopoeia (IP) [1], British Pharmacopoeia (BP) [2] and United States Pharmacopoeia (USP) [3].
Diazepam (DZM), a benzodiazepine and an antipsychotic drug possesses a strong activity against delusions an...

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...ese were optimized for sharper peaks with less asymmetry and for good resolution of IPM and DZM drugs. Initially, mobile phase volume ratio was developed. Methanol and water were tested separately and in combination as a mobile phase. Further, sodium acetate was also used. The addition of sodium acetate to methanol and water increased the pH of mobile phase. Because the mobile phase was basic due to the sodium acetate, pH was decreased by using dilute acetic acid. Elution pH was adjusted to 3.8 with diluted acetic acid. After several chromatographic runs, it was concluded that methanol: water: 0.1%m sodium acetate resulted in a better peak symmetry and good signal to noise (S/N) ratio and good separation of the chromatographic peaks. During the development phase, different pump pressures were tried and were optimized to 12.5 MPa for the stock solution. Optimization

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