TITLE

A Validated RP HPLC Method for Simultaneous Determination of Propranolol hydrochloride and Alprazolam in Bulk and in Pharmaceutical formulations

AUTHOR(S)
Tulja Rani, G.; Gowri Shankar, D.; Kadgapathi, P.; Satyanarayana, B.
PUB. DATE
February 2011
SOURCE
Journal of Pharmacy Research;Feb2011, Vol. 4 Issue 2, p358
SOURCE TYPE
Academic Journal
DOC. TYPE
Article
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 x 4.6 mm, i.d. 5 μ) 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 μg/mL for alprazolam with significantly high value of correlation coefficient (r2 = 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 μg/mL and 1.2 μg/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.
ACCESSION #
74192189

 

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