DEVELOPMENT AND VALIDATION OF RP-HPLC METHOD FOR THE SIMULTANEOUS ESTIMATION OF NICOTINAMIDE AND CLINDAMYCINE IN BULK AND PHARMACEUTICAL FORMULATIONS
Journal Title: Int J of Pharm Res & Analy - Year 2016, Vol 6, Issue 1
Abstract
ABSTRACT The objective of the current study was to develop a simple, accurate, precise and rapid RP-HPLC method and subsequently validate as per ICH guidelines for the determination of Nicotinamide (NIC) and Clindamycine (CLI) using mobile phase [A mixture of 0.02M disodium hydrogen phosphate buffer and acetonitrile (pH-2.9), in the ratio of 71:29 v/v was considered to be the optimal composition] as the solvent. The proposed method involves the measurement of retention time at selected analytical wavelength. 195.0 nm was selected as the analytical wavelength. The retention time of NIC and CLI was found to be 1.864 and 3.642 respectively. The linearity of the proposed method was investigated in the range of 2-10 μg/ml (r = 0.9999) for NIC and 10-50 μg/ml (r = 0.999) for CLI respectively. The method was statistically validated for its linearity, accuracy and precision. Both inter-day and intra-day variation was found to be showing less % RSD (Relative Standard Deviation) value indicating high grade of precision of the method. Keywords: RP-HPLC method, Nicotinamide, Clindamycine, Validation.
Authors and Affiliations
Anil Kumar S. M. *, A. Satishkumar Shetty, N. D. Satyanarayan
Keywords
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