Abstract

“STABILITY INDICATING ANALYTICAL METHOD DEVELOPMENT AND VALIDATION FOR ESTIMATION OF BUPRENORPHINE HCl AND NALOXONE HCl DIHYDRATE”

Vidhi N. Patel*, Mitali H. Jasani, Ankit B. Chaudhary, Bhoomi D. Patel

ABSTRACT

A simple, precise and accurate stability indicating RP-HPLC method was developed and validation for estimation of Buprenorphine HCl (BH) and Naloxone HCl Dihydrate(NHD) The validation was carried out using C18 column (250 x 4.6mm, 5μm) and mobile phase comprised of Acetonitrile and Buffer in proportion of ratio 75:25 degassed under sonication. The flow rate was adjusted to 1 mL/min and the effluent was monitored at 273 nm using PDA detector. The retention time of Buprenorphine hydrochloride and Naloxone hydrochloride dihydrate were 8.198 min and 3.113 min respectively. The method was validated in terms of linearity, precision, accuracy, and specificity, limit of detection and limit of quantization. Linearity of Buprenorphine hydrochloride and Naloxone hydrochloride dihydrate were in the range of 160 – 560 μg/ml and 40–140μg/ml respectively. The percentage recoveries of both the drugs were found to be 100.79 % and 100.42 % for Buprenorphine hydrochloride and Naloxone hydrochloride dihydrate respectively from the synthetic formulation. Acceptable range of degradation was observed for Buprenorphine HCl and Naloxone HCl Dihydrate The method was found to be precise, accurate and specific during the study. The method can be used for routine analysis of marketed products of Buprenorphine hydrochloride and Naloxone hydrochloride dihydrate in synthetic mixture formulation.

Keywords: Buprenorphine hydrochloride, Naloxone hydrochloride dihydrate, Reversed-phase HPLC.