Development of a stability-indicating high-performance liquid chromatographic method for the simultaneous determination of alprazolam and sertraline in combined dosage forms.
The objective of the current study was to develop a validated stability-indicating high-performance liquid chromatographic method for alprazolam and sertraline in combined dosage forms. The method was validated by subjecting the drugs to forced decomposition under hydrolysis, oxidation, photolysis, and thermal stress conditions prescribed by the International Conference on Harmonization. The drugs were successfully separated from major and minor degradation products on a reversed-phase C18 column by using 75 mM potassium dihydrogen phosphate buffer (pH 4.3)-acetonitrile-methanol (50 + 45 + 5, v/v/v) as the mobile phase with determination at 227 nm. The flow rate was 0.9 mL/min. The method was validated with respect to linearity, precision, accuracy, system suitability, and robustness. The responses were linear over the ranges of 1-80 and 5-200 microg/mL for alprazolam and sertraline, respectively. The recoveries of both drugs from a mixture of degradation products were in the range of 97-101%. The utility of the procedure was verified by its application to marketed formulations that were subjected to accelerated stability studies. The method distinctly separated the drugs and degradation products, even in actual samples. The products formed in marketed tablets were similar to those formed during stress studies.
Pathak
Ashutosh
A
The Maharaja Sayajirao University of Baroda, Centre of Relevance and Excellence in Novel Drug Delivery Systems, Pharmacy Department, Quality Assurance Laboratory, G.H. Patel Building, Donor's Plaza, Fatehgunj, Vadodara, Gujarat, India 390 002.
Rajput
Sadhana J
SJ
D000525:Alprazolam / Q000032:analysis*; D002626:Chemistry, Pharmaceutical; D002851:Chromatography, High Pressure Liquid; D004338:Drug Combinations; D004355:Drug Stability; D006358:Hot Temperature; D006868:Hydrolysis; D006993:Hypnotics and Sedatives / Q000032:analysis*; D007202:Indicators and Reagents; D010084:Oxidation-Reduction; D010777:Photochemistry; D012015:Reference Standards; D015203:Reproducibility of Results; D017367:Selective Serotonin Reuptake Inhibitors / Q000032:analysis*; D020280:Sertraline / Q000032:analysis*; D012996:Solutions
D000525:Alprazolam; D004338:Drug Combinations; D006993:Hypnotics and Sedatives; D007202:Indicators and Reagents; D017367:Selective Serotonin Reuptake Inhibitors; D020280:Sertraline; D012996:Solutions