DENSITOMETRY WAS DONE WITH IMAGEJ SOFTWARE TORRENT
A standard drug sample of ALP was provided by Astron Research Centre (Ahmedabad, India) and of PNL by Torrent Research Centre (Ahmedabad, India).
Therefore, it was endeavored to develop an accurate, precise and sensitive alternative RP-HPLC method along with UV-visible spectrophotometric and HPTLC to estimate both the drugs simultaneously in their combined dosage form.Ĭhemicals and reagents. Hence it cannot be extended for characterization of degradation products and impurity profiling of drugs in combination. In the reported RP-HPLC method, more amount of organic phase was used and the optimized mobile phase is not LC-MS compatible. RP-HPLC method is reported for the determination of ALP and PNL in a combined dosage form. Several chromatographic and spectrophotometric methods have also been reported for the determination of PNL from pharmaceutical formulations and biological fluids. Literature survey revealed many chro-matographic and spectrophotometric methods for determination of ALP alone or in combinations with other drugs from pharmaceutical formulations and biological fluids. Both the drugs are official in IP, EP and USP, but PNL is also official in BP. PNL is indicated for the management of various conditions which include hypertension, angina pectoris, tachyarrhythmia, myocardial infarction, control of tachycardia/tremor associated with anxiety. Propranolol hydrochloride (-3-(1-naphthalenyloxy)-2-propanol) is a non selective beta blocker, completely absorbed from gastrointestinal tract. ALP is very effective in the short-term symptomatic relief of moderate to severe anxiety, essential tremor, and panic attacks. DOI: 10.7868/S0044450214070123Īlprazolam (8-chloro- 1-methyl-6-phenyl-4H-triazolo-benzodiazepine) is an orally absorbed benzodiazepine. Keywords: RP-HPLC, HPTLC, UV-visible spectrophotometry, alprazolam, propranolol hydrochloride.
No interference from the tablet excipients was found. All methods were validated according to ICH guidelines and successively applied to marketed pharmaceutical formulation, and the results of all three methods were compared statistically as well. Quantification was achieved over the concentration range of 1-40 and 80-200 p.g/mL for ALP and PNL, respectively. It is based on the determination of PNL at 319.4 nm using its absorptivity value and ALP at 258.2 nm after deduction of absor-bance due to PNL. The third method involves dual wavelength UV-visible spectrophotometric method. Quantification was achieved using UV detection at 248 nm over the concentration range of 100-600 ng/spot and 5-30 ^g/spot for ALP and PNL, respectively. The second method is based on the separation of drugs by HPTLC using chlo-roform-methanol-ammonia 7 : 0.8 : 0.1 (v/v/v) as mobile phase. Quantification was done with photo diode array detection at 255 nm over the concentration ranges of 0.5-50 and 10-250 p.g/mL for ALP and PNL, respectively. Symmetrical peaks with good separation, ALP at 9.3 min and PNL at 3.5 min, were achieved. The first method involves an RP-HPLC separation on the Ci8 column using acetonitrile - 25 mM ammonium acetate buffer and 0.2% triethylamine (pH of buffer adjusted to 4 with glacial acetic acid) in the ratio of 35 : 65 (v/v) as mobile phase. Three accurate, sensitive and reproducible methods are described for the quantitative determination of alprazolam (ALP) and propranolol hydrochloride (PNL) in their combined dosage form. Mehta1ĭepartment of Pharmaceutical Analysis, Institute of Pharmacy, Nirma University Sarkhej-Gandhinagar Highway, Ahmedabad, Gujarat, India - 382481 1E-mail: Received in final form DEVELOPMENT AND VALIDATION OF RP-HPLC, HPTLC AND UV-VISIBLE SPECTROPHOTOMETRIC METHODS FOR SIMULTANEOUS ESTIMATION OF ALPRAZOLAM AND PROPRANOLOL HYDROCHLORIDE IN THEIRĬOMBINED DOSAGE FORM © 2014 D.
0 kommentar(er)
