STRESS DEGRADATION BEHAVIOR OF SAPROPTERIN DI HYDROCHLORIDE AND DEVELOPMENT OF SUITABLE STABILITY-INDICATING RP-HPLC METHOD FOR THE DETERMINATION OF SAPROPTERIN DI HYDROCHLORIDE IN TABLET DOSAGE FORM
Bhavani Vukkum 1*, Siva rao T valluria 1, Jamelunnisa Begumb 2
1Dept of Inorganic and Analytical Chemistry, Andhra University, Visakhapatnam (AP), India.
2Department of Chemistry, St. Theresas College, Eluru, Andhra Pradesh, India.
A novel stability-indicating reversed phase high performance liquid chromatographic method was developed for the quantitative determination of Sapropterin dihydrochloride in Tablet dosage form. The chromatographic separation was achieved on a Waters HPLC , with phenomenex Luna SCX C18, 250 mm × 4.6 mm, 5 μm particle size column with mobile phase containing a isocratic solution ( 30Mm KH2PO4 -PH adjusted to 3.0 with orthophosphoric acid ) .The flow rate was set as 1.2 mL/min and the run time was 15.0 min. The drug substance was subjected to stress studies of acid, base, humidity, Photolytic, oxidation, UVlight, and thermal degradation. Sapropterin dihydrochloride was found to degrade significantly in basic and oxidative stress conditions. The formed degradation products were well resolved from Sapropterin. Degradation products were identified by mass spectrometry, Nuclear magnetic resonance spectroscopy and proposed structures were reported. The formed degradation products. The mass balance was found to be satisfactory in all stress conditions, thus proving the stability indicating capability of the method. The developed RP-HPLC method was validated in agreement with ICH requirements and found to be simple, accurate, precise, linear, specific and suitable for the quantitative determination of Sapropterin dihydrochloride in bulk drug and in its pharmaceutical dosage form.