![Open Access](https://i-scholar.in/lib/pkp/templates/images/icons/fulltextgreen.png)
![Restricted Access](https://i-scholar.in/lib/pkp/templates/images/icons/fulltextred.png)
![Open Access](https://i-scholar.in/lib/pkp/templates/images/icons/fulltextgreen.png)
![Open Access](https://i-scholar.in/lib/pkp/templates/images/icons/fulltext_open_medium.gif)
![Restricted Access](https://i-scholar.in/lib/pkp/templates/images/icons/fulltextred.png)
![Restricted Access](https://i-scholar.in/lib/pkp/templates/images/icons/fulltext_restricted_medium.gif)
Development of Validated Q-absorbance Ratio, Derivative Spectrophotometric and Stability Indicating RP-HPLC Methods for the Simultaneous estimation of Losartan Potassium & Hydrochlorothiazide in Pharmaceutical Dosage Form and Comparison of the Results by ANOVA
Subscribe/Renew Journal
Hypertension is estimated to cause 7.5 million deaths, leading to 12.8 % of the total of all deaths worldwide. In the recent years, the combination of Losartan Potassium and Hydrochlorothiazide has attained significant popularity in reducing the risk of heart diseases particularly in the patients with hypertension and ventricular hypertrophy. The literature survey revealed that there were several chromatographic and spectroscopic methods for the simultaneous estimation of the selected drugs but it was noted that there were no reported comparative studies of the developed methods. Hence the authors attempted to develop new validated Q- absorbance ratio, Derivative spectrophotometric and Stability indicating RP-HPLC methods for the simultaneous estimation of Losartan Potassium and Hydrochlorothiazide in pharmaceutical dosage form. The authors also propose to compare the results obtained by ANOVA. The two Spectrophotometric methods were carried out using an Agilent Cary 60 UV-Visible double beam Spectrophotometer. In Q-absorbance ratio method, samples were measured at two wavelengths, 230 nm (isoabsorptive point) and 225.5 nm (λmax of Hydrochlorothiazide). In Derivative spectroscopy, analysis was performed by derivatizing the zero order spectrum to the corresponding second order spectrum. Stability indicating RP-HPLC method was performed using Eclipse XDB C18 column where the samples were analyzed using a mixture of Acetonitrile and Water in the ratio of 70:30 % v/v as mobile phase at a flow rate of 1 ml/min. The drugs were monitored at 230 nm. The retention times for Losartan Potassium and Hydrochlorothiazide were found to be 1.010 minutes and 1.387 minutes respectively. The proposed methods were validated as per ICH guidelines. The results obtained from the three developed methods were then compared by ANOVA which indicated that the proposed methods can successfully be used for the analysis of Losartan Potassium and Hydrochlorothiazide in bulk or in combined dosage forms.
Keywords
Losartan Potassium, Hydrochlorothiazide, Q-Absorbance Ratio Method, Derivative Spectrophotometric Method, Stability Indicating RP-HPLC, ANOVA.
Subscription
Login to verify subscription
User
Font Size
Information
- Rao PLKM, Venugopal V, Anil Kumar G, Rajesh B, Prasad GAL and Ravindergoud D. Quantitative estimation of Losartan Potassium in pharmaceutical dosage forms by UV spectrophotometry. International Journal of Research in Pharmacy and chemistry. 2011; 1(3): 295-302.
- Hapse SA, Wagh VS, Kadaskar PT, Dokhe MD and Shirsath AS. Spectrophotometric estimation and validation of Hydrochlorothiazide in tablet dosage forms by using different solvents. Der Pharma Chemica. 2012; 4(1): 10-14.
- Neelima Bhatia M, Rituraj Desai and Swapnil Jadhav D. Simultaneous estimation of Losartan Potassium and Hydrochlorothiazide from tablets by first order derivative spectroscopy. International Journal of Pharmacy Pharmaceutical Sciences. 2013; 5(1): 464-466.
- Chaudhari BG and Bhakti Patel. Development and validation of Q-absorbance ratio method for simultaneous estimation of Cefixime and Moxifloxacin in synthetic mixture. American Journal of Pharma Tech Research. 2012; 2(5): 824-832.
- Guilherme Diniz Tavares, Gisele Miki Ishikawa, Talita Ferreira Monteiro, Carolina Zanolini, Érika Rosa Maria Kedor Hackmann, Nádia Araci Bou-Chacra and Vladi Olga Consiglieri. Derivative spectrophotometric method for determination of Acyclovir in polymeric nanoparticles. Quim, Nova. 2012; 35(1): 203-206.
- Pradeep Shelke, Jadhao RG, Chandewar AV and Gadewar CK. A validated RPHPLC method for the simultaneous determination of Hydrochlorothiazide and Losartan Potassium in pharmaceutical formulation. International Journal of Advances in Pharmaceutical Analysis. 2013; 3(4): 665-669.
- Balaswamy B, Venkata Ramana P, Subba Rao B, Sanjeeva P. A New Simple Stability Indicating RP-HPLC-PDA Method for Simultaneous Estimation of Triplicate Mixture of Sofosbuvir, Velpatasvir and Voxilaprevir in Tablet Dosage form. Research Journal of Pharmacy and Technology. 2018; 11(9): 4147-4156.
- Aahraful Islam, Sharif Abuzar Md and Pijush Kumar Paul. Validation of UV-spectrophotometric and RP-HPLC methods for the simultaneous analysis of Paracetamol and Aceclifenac in marketed tablets. International Journal of Pharmacy and Life Sciences. 2011; 2(12): 1267-1275.
- Beckett AH, Stenlake JB. Practical Pharmaceutical Chemistry. 4th> ed. New Delhi: CBS publishers; 1997. p. 286-288.
- Bhusari KP, Khedekar PB, Seema Dhole and Banode VS. Derivative and Q-analysis spectrophotometric methods for estimation of Hydrochlorothiazide and Olmesartan Medoxomil in tablets. Indian Journal of Pharmaceutical Sciences. 2009; 71(5): 505-508.
- Lalitha KV, Kiranjyothi R and Padma B.UV Spectrophotometric method development and validation for the determination of Atenolol and Losartan Potassium by Q-analysis. International Bulletin of Drug Research. 2013; 3(4): 54-62.
- Nevin Erk. Analysis of binary mixtures of Losartan Potassium nd Hydrochlorothiazide by using high performance liquid chromatography, ratio derivative spectrophotometric and compensation technique. Journal of Pharmaceutical and Biomedical Analysis. 2001; 24(4): 603-611.
- Khan Rizwan1 M, Shaikh Anis, Thaker AK. Simultaneous determination and method development for assay of Losartan Potassium and Hydrochlorothiazide drugs in solid dosage form by RP-HPLC. Indian Journal of Pharmaceutical Science and Research. 2012; 2(1): 42-45.
- Arif Hossen Md, Ahsanul Haque, Irin Dewan, Hamidul Kabir ANM, Khalid Hossain Md and Ashraful Islam SM. Development and validation of RP-HPLC method for the simultaneous estimation of Hydrochlorothiazide and Losartan Potassium in tablet dosage form. Dhaka University Journal of Pharmaceutical Sciences. 2011; 10(1): 35-42.
- Dipali Jain S, Deepali Wagh D, Pradip Dhore D, Mundhada DR. Method development and validation of Losartan Potassium and Hydrochlorothiazide in combined dosage form by RP-HPLC. International Journal of Pharma Tech Research. 2012; 4(4): 1581-1585.
- Hossain Md F, Subrata Bhadra, Uttom Kumar and Rouf Abu SS. The ICH guidance in practice: Stress degradation studies on aceclofenac and development of a validated stability-indicating reversed-phase HPLC assay in tablet dosage form. Der Pharma Chemica. 2013; 5(4): 131-146.
- Trivikram Rawat and Pandey IP. Forced degradation studies for drug substance and drug products-scientific and regulatory considerations. Journal of Pharmaceutical Sciences and Research. 2015; 7(5): 238-241.
- Mohammed Ishaq B, Vanitha Prakash K and Krishnamohan G. Development and validation of RP-HPLC method for analysis of Temozolomide in a capsule formulation. International Journal of Chemical analysis. 2013; 11(2): 1055-1063.
- Code Q2R1- Validation of analytical procedures text and methodology, 2005, ICH Harmonized Tripartite Guideline.
- Ashutosh Kumar S, Manidipa Debnath and Seshagiri Rao JVLN. Development and validation of stability indicating RP-HPLC method for simultaneous estimation of Losartan Potassium, Ramipril and Hydrochlorothiazide in bulk as well as in pharmaceutical formulation. Indo American Journal of Pharmaceutical Research. 2013; 3(6): 5423-5445.
- Snyder LR, Kirkland J, Jand Glajch JL. Practical HPLC method development. 2nd ed. Newyork: John wiley and sons; 1997. p. 165.
- Pradeep Shelke, Jadhao RG, Chandewar AV and Gadewar CK. A validated RPHPLC method for the simultaneous determination of Hydrochlorothiazide and Losartan Potassium in pharmaceutical formulation. International Journal of Advances in Pharmaceutical Analysis. 2013; 3(4): 665-669.
![](https://i-scholar.in/public/site/images/abstractview.png)
Abstract Views: 201
![](https://i-scholar.in/public/site/images/pdfview.png)
PDF Views: 0