Development and Validation of stability indicating method for the simultaneous determination of Diazepam and Propranolol Hydrochloride by RP-HPLC
Keywords:
Diazepam Propranolol HCl, HPLC, antihypertensive, anti-anxietyAbstract
simple, selective, rapid, precise and economical reverse phase high pressure liquid chromatographic method has been developed for the simultaneous estimation of Diazepam and Propranolol HCl in pharmaceutical Tablet dosage form. The mobile phase consisted of 65:35 % (v/v) of Methanol & 0.1% v/v ortho phosphoric acid operated on isocratic mode. The flow rate is 1.0 ml/min. Chromatographic separation of Diazepam and Propranolol Hcl was performed on Phenomenox C18 column (150 X 4.6 mm id, ODS 2, 5µm). The wavelength of detection is 222 nm. The injection volume is 20µL. The retention time of Diazepam and Propranolol Hcl are 7.1 ± 0.10 minutes and 2.1 ± 0.10 respectively. The run time of analysis is 8.5minutes. The developed method was validated for parameters such as accuracy, precision, linearity, limit of detection, limit of quantitation and solution stability. The influence of acid, alkaline, oxidative Stress and photolytic stress conditions on both the drugs was studied. Results indicated complete degradation in alkaline medium for Diazepam and Propranolol HCl The proposed method has been successfully used for the estimation in tablet dosage forms.
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