DEVELOPMENT AND VALIDATION OF HIGH-PERFORMANCE THIN-LAYER CHROMATOGRAPHY METHOD FOR SIMULTANEOUS ESTIMATION OF NEBIVOLOL HYDROCHLORIDE AND CILNIDIPINE

MINAL R. GHANTE; NATASHA AKHADE; PREETI GOTA; ATUL NIKAM; SUPRIYA JAGTAP; VANDANA NIKAM

doi:10.22159/ajpcr.2019.v12i4.30569

Authors

MINAL R. GHANTE Sinhgad Technical Education Society, Smt. Kashibai Navale College of Pharmacy, Pune.
NATASHA AKHADE Sinhgad Technical Education Society, Smt. Kashibai Navale College of Pharmacy, Pune.
PREETI GOTA Gahlot Institute of Pharmacy, Koparkhaine, Navi Mumbai.
ATUL NIKAM Sinhgad Technical Education Society, Smt. Kashibai Navale College of Pharmacy, Pune.
SUPRIYA JAGTAP Sinhgad Technical Education Society, Smt. Kashibai Navale College of Pharmacy, Pune.
VANDANA NIKAM Sinhgad Technical Education Society, Smt. Kashibai Navale College of Pharmacy, Pune.

DOI:

https://doi.org/10.22159/ajpcr.2019.v12i4.30569

Keywords:

Method development high-performance thin-layer chromatography, Nebivolol hydrochloride, Cilnidipine, International Council for Harmonisation

Abstract

Objective: The proposed method describes method development and validation of nebivolol hydrochloride and cilnidipine in combined pharmaceutical tablet dosage form by high-performance thin-layer chromatography (HPTLC) having adequate specificity, sensitivity, and reproducibility.

Methods: Nebivolol hydrochloride and cilnidipine drug combination is used for the treatment of hypertension. Precoated aluminum plates with silica gel 60 F254 (E-Merck, Germany) were used for the chromatographic separation which was carried using chloroform:glacial acetic acid:methanol, in 8.5:1:0.5 (v/v/v) as a mobile phase. HPTLC separation of two drugs was carried by densitometric measurement at 270 nm.

Reults: The drugs were satisfactorily resolved with retardation factor values of 0.0.29±0.008 and 0.69±0.007 for nebivolol hydrochloride and cilnidipine, respectively. The method was found to be linear in the range of 100–1000 ng/spot and 50–500 ng/spot for nebivolol hydrochloride and cilnidipine, respectively. The correlation coefficient was found to be 0.989 and 0.996 for nebivolol hydrochloride and cilnidipine, respectively. Limit of detection and limit of quantitation values were 16.395 ng/band and 49.681 ng/band and 31.788ng/band and 96.328 ng/band, respectively. The mean recovery was found to be 100.570–101.936 and 100.269–101.333 for nebivolol hydrochloride and cilnidipine, respectively. The intra- and inter-day precision was found to be within the limit.

Conclusion: A simple, accurate, precise, and sensitive HPTLC method has been developed and validated in combined pharmaceutical tablet dosage form for simultaneous estimation of nebivolol hydrochloride and cilnidipine.

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