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ABSTRACT:
Three simple, fast and economic UV-spectrophotometric methods were developed for the estimation of Bilastine in bulk and pharmaceutical formulation. For zero order (D0) Vax was measured at 281.60 nm. For first order method (D1) amplitude was measured at 280.20 nm (maxima) and 283.60 nm (minima). Bilastine obeyed Beer'sLambert's law in the concentration range of 10-140 pg/ml for both zero order and first order methods. The % RSD value for both intra-day and inter-day precision was less than 2%. The methods were validated as per ICH guidelines for linearity, accuracy, precision and were found to be linear, accurate and precise.
KEYWORDS: Spectrophotometric method, Bilastine, Beer's-Lambert's law, ICH guidelines.
INTRODUCTION:
Bilastine is a new highly selective peripheral histamine H1- receptor antagonist, chemically named as 2-[4-(2{4-[1 -(2-ethoxyethyl)-1H-1, 3 -benzimidazol-2-yl] piperidin-1-yl} ethyl) phenyl]-2-methylpropanoic acid (Figure 1).
Bilastine is a white crystalline powder with molecular formula C28H37N3O3, molecular mass of 463.61g/mole and melting point greater than 1950 C f It belongs to piperidine antihistamine class of drugs. It is a H1 receptor inverse agonist like other antihistamines 2, used for treating allergic disorders such as rhinoconjunctivitis and urticarial 3. Histamine plays a major role in the allergic reaction and is released by mast cell degranulation4. This histamine binds with H1 receptors, activates the receptors and causes allergic reactions. Bilastine binds with H1 receptor and prevents the activation of H1 receptor by histamine. Thus, it acts as an antagonist for histamine. Bilastine shows no cardiotoxic, sedative side effects and undergoes minimal or no first pass metabolism 5. It has less chance to undergo drug-drug interactions. Therefore, it is useful for treating patients suffering with renal/ hepatic dysfunction 6.
Bilastine, a piperidine class antihistamine medication used for the treatment of allergic rhinitis and chronic urticaria. From the review of literature, it was found that very few methods such as LC-MS/MS 7, HPLCfluorescence 8 in biological sample, RP-HPLC 9, HILIC 10 and UV- spectrophotometry 11 are available for estimation of Bilastine. The aim and objective of the present work was to develop and validate as per ICH guidelines 12 a simple, fast, accurate, precise, economic and sensitive method for estimation of Bilastine using UV- spectrophotometry, in both bulk and pharmaceutical formulation, which can be used for routine analysis in QC laboratories.