Acta Scientific Pharmaceutical Sciences (ISSN: 2581-5423)

Perspective Volume 4 Issue 1

Determination of Related Substances in Hydrochlorothiazide Tablets by RP HPLC

K Swarna Priya*, T Rama Mohan Reddy and K Abbulu

Department of Pharmaceutical Analysis, CMR College of Pharmacy, Medchal, India

*Corresponding Author: K Swarna Priya, Department of Pharmaceutical Analysis, CMR College of Pharmacy, Medchal, India.

Received: September 23, 2019; Published: December 10, 2019

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Abstract

A simple, rapid, precise and accurate reversed phase high performance liquid chromatographic method has been developed for the simultaneous estimation of Hydrochlorothiazide and with Impurity-A (Chlorothiazide) by RP-HPLC method. This method uses a Thermosil C18 column (4.0×150mm) 5µ, flow rate was 0.8 min/ml, mobile phase ratio was 65:35% v/v methanol: water pH 3 (pH was adjusted with orthophosphoricacid), detection wavelength was 265nm. The instrument used was WATERS HPLC Auto Sampler, Separation module 2690, photo diode array detector 996, Empower-software version-2. The retention times were found to be 2.566 mins and 3.417 mins. The % purity of Hydrochlorothiazide and with Impurity-A was found to be 99.84% and 97.95% respectively. The system suitability parameters for Hydrochlorothiazide and with Impurity-A (Chlorothiazide) such as theoretical plates and tailing factor were found to be 4668, 1.3 and 6089 and 1.2, the resolution was found to be 6.0. The analytical method was validated according to ICH guidelines (ICH, Q2 (R1)). The linearity study Hydrochlorothiazide and with Impurity-A (Chlorothiazide) was found in concentration range of 5µg-25µg and 50µg-250µg and correlation coefficient (r2) was found to be 0.999 and 0.999, % recovery was found to be 99.56% and 99.47%, % RSD for repeatability was 0.86 and 0.82, % RSD for intermediate precision was 0.44 and 0.19 respectively. The precision study was precise, robust, and repeatable. LOD value was 3.17 and 5.68, and LOQ value was 0.0172 and 0.2125 respectively.

Keywords: Thermosil C18 column (4.0×150mm) 5µ; Hydrochlorothiazide and with Impurity - A (Chlorothiazide); RP-HPLC

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Citation

Citation: K Swarna Priya., et al. "Determination of Related Substances in Hydrochlorothiazide Tablets by RP HPLC 4.1 (2020): 18-24.



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