Pharmaceutical Chemistry Review Volume 1 2015
http://www.bacpl.org/J/pcr
Development and Validation of UV‐ Spectrophotometric Method for Determination of Naftopidil in Bulk and in Formulation Pritam S Jain*, Kajal D Bobade and Sanjay J Surana Department of Pharmaceutical Chemistry, R. C. Patel Institute of Pharmaceutical Education and Research, Shirpur, Dist‐ Dhule,Maharashtra, (India), 425405 North Maharashtra University, Jalgaon pritash79@yahoo.com
Abstract: A simple, rapid, accurate and economical spectrophotometric method has been developed for estimation of Naftopidil from bulk and pharmaceutical formulation. Materials and methods: The λmax of Naftopidil in methanol and water was found to be 281 nm. The drug followed linearity in the concentration range 10‐45 μg/ml with correlation coefficient value 0.998. The proposed method was applied to pharmaceutical formulation and % amount of drug estimated 99.58 % was found in good agreement with the label claim. The accuracy of the method was checked by recovery experiment performed at three different levels i.e., 80%, 100% and 120 %. The % recovery was found to be in the range 98.8%– 99.06%. The low values of % R.S.D. were indicative of the accuracy and reproducibility of the method. The precision of the method was studied as an intra‐day, inter‐day variations and repeatability. The % R.S.D. value less than 2 indicated that the method was precise. Ruggedness of the proposed method was studied with the help of two analysts. The above method was a rapid and cost‐effective quality‐control tool for routine analysis of Naftopidilin bulk and in pharmaceutical dosage form. Key words: Naftopidil; UV‐Spectrophotometric; Quantitative determination
I. Introduction Naftopidil is chemically 1‐[4‐(2‐methoxyphenyl) piperazin‐1‐yl]‐3‐(1‐naphthyloxy) propan‐2‐ol (Fig.1), having molecular formula): C24H28N2O3 with molecular weight 392.5. It is white to off white crystalline powder with melting point 127.70C and soluble in methanol[1]. It acts as an anti‐hypertensive agent.Naftopidil exerts its antihypertensive action via alpha1‐adrenoceptor blockage and Ca2+antagonism in vascular smooth muscle[2]. Naftopidil, a phenylpiperazine derivative, is a novel alpha1‐adrenoceptor antagonist and is a new drug for the bladder outlet obstruction in patients with benign prostatic hyperplasia (BPH). Naftopidil competitively inhibited specific [3H]prazosin binding in prostatic membranes of humans. Naftopidil was selective for the alpha 1d‐ adrenoceptor with approximately 3‐ and 17‐fold higher affinity than for the alpha 1a‐ and alpha 1b‐adrenoceptor subtypes, respectively. In clinical studies, naftopidil has been demonstrated to be effective in the treatment of bladder outlet obstruction in patients with BPH[3]. In addition to the antagonistic action of this agent on the alpha1 adrenergic receptors of prostatic smooth muscle naftopidil may also act on the lumbosacral cord and thus may improve collecting disorders in patients with benign prostatic hyperplasia[4]. In this way, they reduce the pressure on the urethra and so help increase the flow of urine. Newly developed alpha1 adrenoceptor antagonists including naftopidil are free from the ʺprazosin‐likeʺ side effect of orthostatic hypotension and associated symptoms[5]. Naftopidil a novel antihypertensive compound, possesses Agonistic properties in addition to being an alpha1 adrenoceptor antagonist[6]. Various methods are reported for the analysis of individual drug as HPLC[7‐8], and LCMS/MS[9] but no spectrophotometric method is reported estimation of drug in pharmaceutical dosage form. Accordingly, the objective of this study is to develop and validate the spectrophotometric method for
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