Int J App Pharm, Vol 16, Issue 4, 2024, 190-198Original Article

ANALYTICAL METHOD DEVELOPMENT, VALIDATION AND SOLUBILITY ESTIMATION OF NICARDIPINE HCL IN VARIOUS OIL SOLVENTS, SURFACTANTS AND COSURFACTANTS

RAHUL Y. PAGAR*, AVINASH B. GANGURDE

Department of Pharmaceutics, K. B. H. S. S. Trust’s Institute of Pharmacy, Malegaon, Nashik-423105, Maharashtra, India
*Corresponding author: Rahul Y. Pagar; *Email: raahulpagar@gmail.com

Received: 29 Apr 2024, Revised and Accepted: 05 Jun 2024

ABSTRACT

Objective: This study is focused on the development of an analytical method and the evaluation of the solubility of Nicardipine HCl (NHCL) in various oil solvents, surfactants, and cosurfactants using the saturated solubility determination method employing UV Spectrophotometry.

Methods: Lipophilic solvents such as Caprylic Capric, Soyabean oil, linseed oil, Coconut oil, Sunflower oil, Corn oil, Olive oil, Peanut oil, and Cottonseed oil were utilized, along with surfactants Tween 60 and Tween 80, and cosurfactants PEG 200 and Transcutol HP. Analytical validation parameters, including linearity and range, precision, limit of Detection (LOD), limit of Quantification (LOQ), ruggedness, robustness, and accuracy, were assessed according to the International Council for Harmonisation (ICH) guidelines. The solubility of NHCL in all of the aforementioned solvents was evaluated using the saturated solubility determination method.

Results: Linearity analysis revealed a linear relationship, determined by an R2 value between concentration and absorbance. Intra-day precision demonstrates method reliability, with all Percent Relative Standard Deviation (%RSD) values ranging between 0.8426 and 1.9417%. LOD and LOQ values ranged between 1.1478 and 8.1632 µg/ml and 3.4783 and 24.7368 µg/ml, respectively. Ruggedness analysis exhibited good control over external experimental factors, with %RSD between 0.3433 and 1.9183%. Robustness assessment demonstrated consistent performance even with slight changes in environmental conditions, with %RSD between 0.5450 and 1.6443%. Accuracy study indicated % recovery values between 98.53 and 100.89%, suggesting minimal interference from excipients in the formulation.

Conclusion: Caprylic Capric, as an oil/triglyceride, exhibited a solubility of 0.94 mg/ml. Tween-80, as a surfactant, showed a solubility of 23.58 mg/ml, and Transcutol HP, as a cosurfactant, demonstrated a solubility of 38.18 mg/ml for NHCL

Keywords: Solubility, Bioavailability, Nicardipine HCl, Caprylic capric, Tween 80, Transcutol HP

© 2024 The Authors. Published by Innovare Academic Sciences Pvt Ltd. This is an open access article under the CC BY license (https://creativecommons.org/licenses/by/4.0/)
DOI: https://dx.doi.org/10.22159/ijap.2024v16i4.51264 Journal homepage: https://innovareacademics.in/journals/index.php/ijap

INTRODUCTION

Nicardipine HCl (NHCL) falls under the category of dihydropyridine derivatives. NHCL represents the monohydrochloride salt of 2,6-dimethyl-5-methoxycarbonyl-3-(2-N-benzyl-methylamino) ethoxycarbonyl-4-(3-nitrophenyl)-1,4 dihydropyridine hydrochloride. This substance presents as a greenish-yellow crystalline powder with a subtle bitter taste and no discernible odour [1].

NHCL is a calcium channel blocker with potent vasodilator and antihypertensive characteristics. It undergoes rapid absorption primarily from the jejunum and ileum, key segments of the digestive tract [2]. It may be administered alone or in combination with an angiotensin-converting enzyme inhibitor. Additionally, NHCL dilates coronary arteries; thereby augmenting blood supply to the myocardium [3-5]. NHCL is classified as a BCS class II drug, indicating high permeability but low solubility. Water solubility significantly affects drug dissolution and bioavailability. Compounds with greater solubility typically exhibit enhanced absorption and increased bioavailability [6-18].

The solubility of BCS class II drugs can be improved through the dry emulsion techniques, employing lyophilization [19-25].

This study focuses on comprehensive exploration of the solubility behaviour of NHCL, an important cardiovascular drug, in a wide range of oil solvents, surfactants, and cosurfactants. By examining the solubility profiles across different solvents, this research will help for enhancing the bioavailability and efficacy of NHCL formulations. Furthermore, the inclusion of surfactants and cosurfactants in the investigation reflects a contemporary approach to pharmaceutical formulation, considering the importance of solubility enhancement techniques in improving drug delivery systems.

Moreover, the analytical method development and validation aspects underscore the rigor and reliability of the analytical techniques employed in quantifying NHCL concentrations. The validation process ensures the linearity, precision, LOD, LOQ, ruggedness, robustness, and accuracy of the analytical method, thus ensuring the credibility of the experimental results. This contributes to the scientific community by providing a validated analytical method that can be utilized for routine quality control analysis of NHCL formulations.

In essence, this study amalgamates analytical chemistry principles with pharmaceutical formulation science to address the critical need for robust analytical methods and enhanced solubility understanding in the development of NHCL formulations. Its comprehensive approach and scientific rigor make it a valuable contribution to both academia and the pharmaceutical industry, with potential implications for improving therapeutic outcome and patient care. Top of Form

MATERIALS AND METHODS

Materials

NHCL, Caprylic Capric, and Transcutol HP were obtained as gift samples from Subhash Chemical Industries Pvt. ltd. Polyethylene glycol 200 (PEG-200), Tween-60, and Tween-80 were purchased from Vishal Chemicals. The Coconut Oil (Marico limited, Mumbai), Soyabean Oil (Pataldhamal Wadhwani Agri Tech Pvt. ltd.), Linseed Oil (Mahesh Agro Food Industries, Rajasthan), Corn Oil (Cargill India Pvt. ltd., Mumbai), Cottonseed Oil (Ashwin Vanaspati Industries Pvt. ltd.), Olive Oil (V. G. Kannan Foods Pvt. ltd., Mumbai), and Peanut Oil (Nav Maharashtra Agro Industries Pvt. ltd., Pune) were purchased from the suppliers.

Determination of ʎ max of NHCL in various solvent

A standard stock solution containing 100 µg/ml of NHCL was prepared by dissolving 10 mg of NHCL in Caprylic Capric, Soyabean Oil, Linseed Oil, Coconut Oil, Sunflower Oil, Corn Oil, Olive Oil, Peanut Oil, Cottonseed Oil, Tween-60, Tween-80, PEG-200, and Transcutol HP, and analysed on UV Spectrophotometer between 400-200 nm, and λ max was recorded.

Linearity and range

For the linearity study, five different dilutions of NHCL were prepared in each solvent as shown in table 1 and used for calibration curve plot (n=3). The intercept and slope for each solvent used were determined from the calibration curve.

Precision

Solutions of dilutions, as shown in table 2, were used to determine precision. Six samples (n=6) of the same concentration were used, and absorbance was recorded. Mean, Standard Deviation (SD), and % RSD were calculated.

Table 1: Solvent and different concentration (µg/ml) used for linearity study

Solvent Concentration (µg/ml) Solvent Concentration (µg/ml)

Caprylic Capric

Linseed Oil

 100, 150, 200, 250, 300

Corn Oil

Peanut Oil

 50, 100, 150, 200, 250
Sunflower Oil 50, 75, 100, 125, 150 Soyabean Oil 20, 40, 60, 80, 100.
Olive Oil 100, 120, 140, 160, 180 Cottonseed Oil 100, 150, 200, 250, 300
Tween-80 10, 20, 30, 40, 50 Tween-60 50, 70, 90, 110, 130
PEG-200 10, 15, 20, 25, 30 Transcutol HP 20, 40, 60, 80, 100

Table 2: Solvent and different concentration (µg/ml) used for precision study

Concentration (µg/ml) Solvent Concentration (µg/ml) Solvent
200 Caprylic Capric and Cottonseed oil 150 Linseed Oil, Corn Oil and Peanut Oil
120 Olive Oil 100 Coconut Oil
90 Tween-60 75 Sunflower Oil
60 Soyabean Oil and Transcutol HP 30 Tween-80 and PEG-200

LOD and LOQ

LOD and LOQ were calculated for each used solvent by using formula for

Ruggedness

Solutions of dilutions, as shown in table 3, were used to study ruggedness. Two analysts at the same environmental condition and on the same instrument conducted the experiment. Three samples (n=3) of the same concentration were used, and absorbance was recorded mean absorbance, SD, and %RSD were calculated.

Table 3: Solvent and different concentration (µg/ml) used for ruggedness study

Concentration (µg/ml) Solvent Concentration (µg/ml) Solvent
200 Cottonseed oil 150 Caprylic Capric, Corn Oil and Peanut Oil
125 Sunflower Oil
100 Linseed Oil 120 Coconut Oil and Olive Oil
80 Soyabean Oil 90 Tween-60
30 Tween-80 and PEG-200 60 Transcutol HP

Robustness

Solutions of dilutions, as shown in table 4, were used to study robustness at two different temperature conditions (Room Temperature-36 °C and 20 °C). Six samples (n=6) of the same concentration were used, and absorbance was recorded. Mean absorbance, SD, and %RSD were calculated.

Accuracy/% recovery

Three different concentrations of 80%, 100%, and 120% of NHCL in each solvent were prepared using the label claim of the marketed product and bulk NHCL. Three samples (n=3) of each concentration were used, and absorbance was recorded. Mean absorbance, SD, and % Recovery were calculated [26-33].

Table 4: Solvent and different concentration (µg/ml) used for robustness study

Concentration (µg/ml) Solvent Concentration (µg/ml) Solvent
200 Cottonseed oil 150 Caprylic Capric, Linseed Oil, Corn Oil and Peanut Oil
120 Olive Oil
100 Coconut Oil 90 Tween-60
75 Sunflower Oil 60 Transcutol HP and Soyabean Oil
30 Tween-80 and PEG-200

Saturated solubility study

Excess amounts of the drug were added to 10 ml of an appropriate solvent in glass vials. These vials were then placed on an orbital shaker and subjected to agitation for 48 h at a speed of 50 rpm, maintaining a constant temperature of approximately 37±0.5 °C. Subsequently, the resulting samples were filtered using syringe filters with a pore size of 0.22 µm. The filtrate was collected and appropriately diluted with the same solvent. The absorbance of the drug was then analysed using a UV-Visible Spectrophotometer at the pre-scanned λmax in the respective solvent (n=3). Finally, the mean absorbance values were converted into concentrations using a standard curve of the drug in the solvent [34].

RESULTS AND DISCUSSION

Linearity and Range

Table 4 represents the λ max, concentration range, and mean absorbance for different dilutions of the solvents used. Fig. 1 to 13 show concentration-versus-absorbance graphs, along with the corresponding R2 values for each solvent.

Linearity, studied by the R² value, was found to be between 0.9873 and 0.9999, revealing a linear relationship between the concentration and absorbance of NHCL in various solvents. These values are close to those determined by Naik and Pai (2013) and Nagaraju et al. (2014), which were 0.991 and 0.997, respectively [35, 36]. Apridamayanti P. et al.(2024), discussed the significance of R2 value in linearity study [37].

Table 4: λ max, concentration range, and mean absorbance for NHCL in solvents used

Caprylic Capric (λ max= 349 nm)
Conc. (µg/ml) 100 150 200 250 300
mean Absorbance 0.1601±0.0043 0.2615±0.0060 0.3527±0.0038 0.4464±0.0092 0.5480±0.0099
Soyabean Oil (λ max= 345 nm)
Conc. (µg/ml) 20 40 60 80 100
mean Absorbance 0.2762±0.0074 0.3225±0.0053 0.4057±0.0052 0.4966±0.0049 0.5875±0.0025
Linseed Oil (λ max= 376 nm)
Conc. (µg/ml) 100 150 200 250 300
mean Absorbance 0.2092±0.0015 0.2891±0.0049 0.4248±0.0052 0.5749±0.0062 0.6894±0.0064
Coconut Oil (λ max= 349 nm)
Conc. (µg/ml) 60 80 100 120 140
mean Absorbance 0.3628±0.0096 0.4668±0.0049 0.5403±0.0045 0.6195±0.0032 0.7248±0.0052
Sunflower Oil (λ max= 344 nm)
Conc. (µg/ml) 50 75 100 125 150
mean Absorbance 0.1482±0.0044 0.3366±0.0050 0.5100±0.0088 0.6504±0.0047 0.7904±0.0016
Corn Oil (λ max= 376 nm)
Conc. (µg/ml) 50 100 150 200 250
mean Absorbance 0.1032±0.0029 0.2240±0.0053 0.3364±0.0047 0.3960±0.0045 0.5004±0.0082
Olive Oil (λ max.= 330 nm)
Conc. (µg/ml) 100 120 140 160 180
mean Absorbance 0.4038±0.0058 0.4570±0.0030 0.5118±.0040 0.5705±0.0055 0.6096±0.0083
Peanut Oil (λ max= 321 nm)
Conc. (µg/ml) 50 100 150 200 250
mean Absorbance 0.1321±0.0043 0.2802±0.0035 0.3811±0.0041 0.5141±0.0050 0.6165±0.0071
Cottonseed Oil (λ max= 366 nm)
Conc. (µg/ml) 100 150 200 250 300
mean Absorbance 0.1582±0.0046 0.2873±0.0061 0.3882±0.0072 0.5325±0.0083 0.6097±0.0076
Tween-60 (λ max= 371 nm)
Conc. (µg/ml) 50 70 90 110 130
mean Absorbance 0.1650±0.0059 0.2293±0.0095 0.2604±0.0076 0.3151±0.0072 0.3569±0.0066
Tween-80 (λ max= 346 nm)
Conc. (µg/ml) 10 20 30 40 50
mean Absorbance 0.1101±0.0047 0.3048±0.0073 0.4934±0.0076 0.6631±0.0073 0.8519±0.0080
PEG-200 (λ max= 358 nm)
Conc. (µg/ml) 10 15 20 25 30
mean Absorbance 0.1026±0.0029 0.1582±0.0057 0.2220±0.0077 0.2850±0.0043 0.3579±0.0083
Transcutol HP (λ max= 351 nm)
Conc. (µg/ml) 20 40 60 80 100
mean Absorbance 0.2009±0.0058 0.4001±0.0093 0.6080±0.0099 0.8010±0.0094 0.9975±0.0030

The data is expressed as a mean±SD, n=3

Fig. 1: NHCL in caprylic capric Fig. 2: NHCL in soyabean oil

Precision

Table 5 shows the Precision study and its % RSD for each solvent used.

Intra-day precision demonstrates method reliability, with all %RSD values ranging between 0.8426% and 1.9417%. According to Patil (2017) and Snyder et al. (2010), for a standard solution containing 100% analyte, the % RSD should be less than 2% to meet the acceptable precision criteria. This means that the variability in results obtained from repeated analyses of the standard solution should not exceed 2% of the mean value. When analyzing a sample solution with 1% analyte content, the acceptable %RSD is specified to be below 2.7%. This slightly relaxed criterion reflects the lower concentration of analyte in the sample solution, allowing for a slightly higher degree of variability while still maintaining acceptable precision standards [38, 39].

Fig. 3: NHCL in linseed oil Fig. 4: NHCL in coconut oil
Fig. 5: NHCL in sunflower oil Fig. 6: NHCL in corn oil
Fig. 7: NHCL in olive oil Fig. 8: NHCL in peanut oil
Fig. 9: NHCL in cottonseed oil Fig. 10: NHCL in tween 60
Fig. 11: NHCL in tween 80 Fig. 12: NHCL in PEG200

Fig. 13: NHCL in transcutol HP

Table 5: Precision study and its % RSD values for NHCL in solvents used

Solvent Mean absorbance±SD* %RSD
Caprylic Capric 0.3519±0.0047 1.2259
Soyabean Oil 0.4065±0.0037 1.6034
Linseed Oil 0.2866±0.0047 1.3558
Coconut Oil 0.5424±0.0039 0.8804
Sunflower Oil 0.3345±0.0041 0.8426
Corn Oil 0.3375±0.0037 1.1738
Olive Oil 0.4570±0.0033 1.0597
Peanut Oil 0.3842±0.0043 1.2025
Cottonseed Oil 0.3866±0.0052 1.1553
Tween-60 0.2638±0.0041 1.9417
Tween-80 0.4970±0.0064 1.1267
PEG-200 0.3581±0.0057 1.4729
Transcutol HP 0.6079±0.0070 1.1551

*The data is expressed as a mean±SD, n=6

Table 6: LOD and LOQ values for NHCL in solvents used

Solvent LOD (µg/ml) LOQ (µg/ml)
Caprylic Capric 8.1632 24.7368
Soyabean Oil 3.0525 9.2500
Linseed Oil 6.2405 18.8000
Coconut Oil 2.9250 8.8636
Sunflower Oil 2.1141 6.4063
Corn Oil 6.4263 19.4737
Olive Oil 4.1885 12.6923
Peanut Oil 5.9125 17.9167
Cottonseed Oil 7.4609 22.6087
Tween-60 5.8826 17.8261
Tween-80 1.1478 3.4783
PEG-200 1.4695 4.4531
Transcutol HP 2.3100 7.0000

LOD and LOQ

Table 6 shows the LOD and LOQ values for each solvent used.

The calculated LOD and LOQ values ranged between 1.1478 and 8.1632 µg/ml and 3.4783 and 24.7368 µg/ml, respectively. lOD and lOQ are derived from a linear regression analysis applied to a standard curve. These values indicate the method's sensitivity and the lowest concentration of NHCL that can be reliably detected and quantified with acceptable precision and accuracy [40].

Ruggedness

Table 7 shows Ruggedness study and its %RSD value for each solvent used by different analyst.

Ruggedness analysis exhibited good control over external experimental factors, with %RSD between 0.3433% and 1.9183%.

Table 7: Ruggedness study and its %RSD for NHCL in solvents used by different analyst

Solvent Conc. (µg/ml) Analyst Mean absorbance±SD* %RSD
Caprylic Capric 150 I 0.2659±0.0039 1.4643
II 0.2608±0.0045 1.7066
Soyabean Oil 80 I 0.4966±0.0049 0.9892
II 0.4929±0.0030 0.6135
Linseed Oil 100 I 0.2092±0.0015 0.7240
II 0.2178±0.0037 1.7173
Coconut Oil 120 I 0.6195±0.0032 0.5131
II 0.6149±0.0041 0.6634
Sunflower Oil 125 I 0.6504±0.0047 0.7298
II 0.6516±0.0022 0.3433
Corn Oil 150 I 0.3364±0.0047 1.3854
II 0.3336±0.0052 1.5544
Olive Oil 120 I 0.4570±0.0030 0.6476
II 0.4529±0.0034 0.7594
Peanut Oil 150 I 0.3811±0.0041 1.0768
II 0.3836±0.0022 0.5640
Cottonseed Oil 200 I 0.3882±0.0072 1.8570
II 0.3840±0.0050 1.3091
Tween-60 90 I 0.2604±0.0023 0.8498
II 0.2597±0.0050 1.9183
Tween-80 30 I 0.4934±0.0076 1.5419
II 0.4875±0.0051 1.0368
PEG-200 30 I 0.3583±0.0037 1.0236
II 0.3563±0.0044 1.2255
Transcutol HP 60 I 0.6080±0.0099 1.6276
II 0.6090±0.0046 0.7473

*The data is expressed as a mean±SD, n=3

Robustness

Table 8 shows Robustness study and its % RSD of each solvent used at two different temperature conditions.

Robustness assessment demonstrated consistent performance even with slight changes in environmental conditions, with %RSD between 0.5450% and 1.6443%. The %RSD values fell within the acceptable range, indicating its reliability [41, 42].

Table 8: Robustness study and its %RSD for NHCL in solvents usedat two different temperature conditions

Solvent Conc. (µg/ml) Temperature Mean absorbance±SD* %RSD
Caprylic Capric 150 Room Temp. 0.2525±0.0029 1.1617
20 °C 0.2547±0.0037 1.4625
Soyabean Oil 60 Room Temp. 0.4134±0.0036 0.8730
20 °C 0.4065±0.0037 0.8987
Linseed Oil 150 Room Temp. 0.2934±0.0034 1.1455
20 °C 0.2866±0.0047 1.6443
Coconut Oil 100 Room Temp. 0.5489±0.0047 0.8336
20 °C 0.5424±0.0039 0.7110
Sunflower Oil 75 Room Temp. 0.3402±0.0041 1.2141
20 °C 0.3345±0.0041 1.2257
Corn Oil 150 Room Temp. 0.3446±0.0039 1.1389
20 °C 0.3375±0.0037 1.0970
Olive Oil 120 Room Temp. 0.4573±0.0025 0.5450
20 °C 0.4570±0.0033 0.7281
Peanut Oil 150 Room Temp. 0.3872±0.0024 0.6128
20 °C 0.3842±0.0043 1.1274
Cottonseed Oil 200 Room Temp. 0.3888±0.0044 1.1197
20 °C 0.3866±0.0052 1.3468
Tween-60 90 Room Temp. 0.2536±0.0035 1.3889
20 °C 0.2627±0.0041 1.5437
Tween-80 30 Room Temp. 0.4981±0.0056 1.1293
20 °C 0.4970±0.0064 1.2807
PEG-200 30 Room Temp. 0.3560±0.0032 0.8947
20 °C 0.3581±0.0057 1.5958
Transcutol HP 60 Room Temp. 0.6109±0.0039 0.6429
20 °C 0.6079±0.0070 1.1490

*The data is expressed as a mean±SD, n=6

Accuracy/% recovery

Table 9 shows the % recovery values for each solvent used at 80%, 100% and 120% concentrations.

The accuracy study indicated % recovery values between 98.53% and 100.89%, suggesting minimal interference from excipients in the formulation. The capability to precisely recover known concentrations of the drug from the sample solution enhances confidence in the accuracy and suitability of the method [43].

Solubility estimation

Table 10 shows the solubility of NHCL in each solvent used.

Among the oils/triglycerides, Caprylic Capric exhibits the highest solubility, followed by coconut oil, soyabean oil, linseed oil, peanut oil, sunflower oil, olive oil, corn oil, and cottonseed oil, in descending order. As for surfactants, Tween-80 demonstrates the highest solubility, followed by Tween-60. Among the cosurfactants, Transcutol HP displays the highest solubility, followed by PEG-200.

Table 9: % recovery values for NHCL in solvents used at 80%, 100% and 120% concentrations

Solvent Concentration Mean conc. (µg/ml)±SD* % Recovery
Caprylic Capric 180 µg/ml (80%) 179.0180±2.1862 99.45
200 µg/ml (100%) 199.0042±1.9279 99.94
220 µg/ml (120%) 219.8057±1.7199 99.91
Soyabean Oil 180 µg/ml (80%) 179.7038±1.9667 99.84
200 µg/ml (100%) 199.5064±0.5552 99.75
220 µg/ml (120%) 219.7607±1.1004 99.89
Linseed Oil 180 µg/ml (80%) 179.1205±1.9218 99.51
200 µg/ml (100%) 200.1043±2.0082 100.05
220 µg/ml (120%) 219.9647±1.0542 99.98
Coconut Oil 180 µg/ml (80%) 181.5981±1.3291 100.89
200 µg/ml (100%) 199.6997±1.1405 99.85
220 µg/ml (120%) 220.3178±1.1644 100.14
Sunflower Oil 180 µg/ml (80%) 177.3564±0.3345 98.53
200 µg/ml (100%) 198.6161±1.9179 99.31
220 µg/ml (120%) 218.4052±1.4161 99.28
Corn Oil 180 µg/ml (80%) 178.6710±1.4671 99.26
200 µg/ml (100%) 199.5223±1.4236 99.76
220 µg/ml (120%) 221.8568±1.7821 100.84
Olive Oil 180 µg/ml (80%) 180.2235±1.3469 100.12
200 µg/ml (100%) 200.1447±1.0870 100.07
220 µg/ml (120%) 221.0310±1.0095 100.47
Peanut Oil 180 µg/ml (80%) 178.6482±0.4795 99.25
200 µg/ml (100%) 199.9764±2.0900 99.99
220 µg/ml (120%) 219.8079±1.3022 99.91
Cottonseed Oil 180 µg/ml (80%) 179.6005±2.5452 99.78
200 µg/ml (100%) 199.3700±1.2449 99.69
220 µg/ml (120%) 219.5024±1.1784 99.77
Tween-60 180 µg/ml (80%) 179.6705±1.2568 99.82
200 µg/ml (100%) 199.4661±1.0072 99.73
220 µg/ml (120%) 219.4320±0.7813 99.74
Tween-80 36 µg/ml (80%) 35.9756±0.2878 99.93
40 µg/ml (100%) 39.5007±0.0753 98.75
44 µg/ml (120%) 43.8582±0.0806 99.68
PEG-200 36 µg/ml (80%) 35.9108±0.1903 99.75
40 µg/ml (100%) 39.8322±0.2870 99.58
44 µg/ml (120%) 43.6019±0.5236 99.10
Transcutol HP 72 µg/ml (80%) 71.7568±0.6422 99.66
80 µg/ml (100%) 79.2883±0.2243 99.11
88 µg/ml (120%) 87.6689±0.2113 99.62

*The data is expressed as a mean±SD, n=3

Table 10: Solubility of NHCL in solvents used

Solvent Mean absorbance±SD of unknown* Concentration of unknown (µg/ml) Dilution Solubility (mg/ml)
Caprylic Capric 0.1503±0.0040 94.13 10 0.94
Soyabean Oil 0.4180±0.0057 60.08 10 0.60
Linseed Oil 0.0674±0.0047 52.80 10 0.53
Coconut Oil 0.4319±0.0092 74.81 10 0.75
Sunflower Oil 0.1246±0.0049 43.56 10 0.44
Corn Oil 0.6887±0.0072 342.64 1 0.34
Olive Oil 0.2397±0.0081 37.21 10 0.37
Peanut Oil 0.1370±0.0073 47.38 10 0.47
Cottonseed Oil 0.6535±0.0077 311.75 1 0.31
Tween-60 0.4711±0.0054 176.85 100 17.69
Tween-80 0.3663±0.0058 23.58 1000 23.58
PEG-200 0.2924±0.0073 25.26 1000 25.26
Transcutol HP 0.3839±0.0069 38.18 1000 38.18

*The data is expressed as a mean±SD, n=3

CONCLUSION

Analytical method validation for each solvent was successfully conducted in accordance with ICH guidelines. Caprylic Capric, as an oil/triglyceride, Tween-80 as a surfactant and Transcutol HP as a cosurfactant, exhibited high solubility for NHCL.

ACKNOWLEDGEMENT

The authors are thankful to Subhash Chemical Industries Pvt. ltd. for providing the gift sample of Caprylic Capric, and Transcutol HP and KBHSS Trust’s Institute of Pharmacy, Malegaon, Nashik for providing facilities to conduct the research.

FUNDING

Nil

AUTHORS CONTRIBUTIONS

Rahul Y. Pagar: Conceptualization, Investigation, Data Analysis, Writing-original Draft.

Avinash B. Gangurde: Supervision, Data Analysis, Writing-reviewing and editing.

CONFLICT OF INTERESTS

Declared none

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