Quantitative analysis of berberine inBerberis aristatafruits and in a traditional anti-inflammatory unani formulation by use of a validated HPLC method

Abstract

A validated reversed-phase HPLC method has been developed for quantitative analysis of berberine in Berberis aristata fruits and in a polyherbal formulation. Separation of berberine was achieved on a C 18 column with a mobile phase consisting of a 10-80% acetonitrile gradient in 0.05% aqueous orthophosphoric acid. The flow rate was 1 mL min −1 . Detection was at 266 nm. A sharp, well defined peak was obtained at a retention time of 10.0 ± 0.4 min. The method was validated in accordance with ICH guidelines for accuracy, precision, robustness, and the limits of detection (LOD) and quantification (LOQ). Results from linear regression analysis were indicative of a good linear relationship (r 2 = 0.998 ± 0.0011) in a wide concentration range (5-500 μg mL −1 ). LOD and LOQ were 1.5 and 5.3 μg mL −1 , respectively. Satisfactory recovery results (94.6-103.1%) were obtained by the method of standard addition. Intra-day, inter-day, and intersystem precision was satisfactory, with relative standard deviation in the range 0.7-1.8%. The berberine content of fruit of Berberis aristata and the herbal formulation were 0.033% and 0.0089% (w/w), respectively. This HPLC method for quantification of berberine can be used for quality control and standardization of several crude drugs and different herbal formulations in which berberine is present as a phyto constituent.

Development and validation of HPLC method for simultaneous estimation of piperine and guggulsterones in compound Unani formulation (tablets) and a nanoreservoir system

“…Method validation was carried out to confirm that the analytical method employed for this specific analysis is suitable for its intended use. The proposed method was validated as per the ICH guidelines and similar to the methods reported (International Conference on Harmonization, 1996;Ansari et al, 2005;Ahmad et al, 2008;Bhat et al, 2008;Alam et al, 2009;Kamal et al, 2011) for parameters such as linearity, accuracy, precision, LOD and LOQ and robustness. The accuracy of the proposed method was determined by spiking previously analyzed test solutions with the standards.…”

Simultaneous estimation of anti-cancer terpenoids in pharmaceutical nanoformulation by RP-HPLC and HPTLC

“…Both the developed chromatographic methods were validated as per the ICH guidelines (ICH, 2005), similarly as work reported by laboratory [6][7][8][9] for accuracy, precision, repeatability, robustness, limit of detection, and limit of quantitation.…”

In Vitro Antioxidant Activity and HPTLC Analysis of Borago officinalis Linn.

“…The developed method was validated as per ICH guidelines 13 still, there are several chromatographic HPLC and HPTLC methods have been developed and validated by the laboratory, [19][20][21][22] which are in use for the quality assessment of herbal drugs.…”